Subjects: United States. Department of Health and Human Services. - Digital Collections - National Library of Medicine Search Results

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1. The "deemed to be a license" provision of the BPCI Act: questions and answers

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, March 2020
Subject(s):: Biological Products
Drug Approval
Licensure
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

2. 30-Day notices, 135-day premarket approval (PMA) supplements and 75-day humanitarian device exemption (HDE) supplements for manufacturing method or process changes: guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, December 16, 2019
Subject(s):: Device Approval -- standards
Equipment and Supplies -- standards
Manufactured Materials -- standards
Device Approval -- legislation & jurisprudence
Time Factors
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.

3. 510(k) third party review program: guidance for industry, Food and Drug Administration staff, and third party review organizations

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, March 12, 2020
Subject(s):: Device Approval
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

4. ANDA submissions--amendments to abbreviated new drug applications under GDUFA

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, July 2018
Subject(s):: Drugs, Generic -- standards
Investigational New Drug Application
Drug Approval
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

5. ANDA submissions: amendments and requests for final approval to tentatively approved ANDAs

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, September 2020
Subject(s):: Drug Approval
Drug Industry
Drugs, Generic
Therapeutic Equivalency
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

6. Acceptance and filing reviews for premarket approval applications (PMAs): guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Biologics Evaluation and Research, December 16, 2019
Subject(s):: Device Approval -- standards
Checklist
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

7. Access and use of electronic health information by individuals with cancer: 2017-2018

Author(s):: Johnson, Christian, MPH, author
Krakow, Melinda, author
Patel, Vaishali, author
Publication:: Washington, DC : U.S. Department of Health and Human Services, Office of the National Coordinator for Health Information Technology, January 2020
Subject(s):: Electronic Health Records -- statistics & numerical data
Facilities and Services Utilization -- statistics & numerical data
Health Services Accessibility -- statistics & numerical data
Neoplasms
United States
United States. Department of Health and Human Services.

8. The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program: guidance for industry, accreditation bodies, testing laboratories, and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, September 25, 2020
Subject(s):: Accreditation
Equipment and Supplies
Materials Testing
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

9. Acne vulgaris: establishing effectiveness of drugs intended for treatment

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, May 2018
Subject(s):: Acne Vulgaris -- drug therapy
Drug Evaluation -- standards
Clinical Trials as Topic -- standards
Endpoint Determination
Research Design -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

10. Adaptive designs for clinical trials of drugs and biologics

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, November 2019
Subject(s):: Adaptive Clinical Trials as Topic -- standards
Investigational New Drug Application
Adaptive Clinical Trials as Topic -- ethics
Biological Products
Drugs, Investigational
Research Design
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

11. Administrative procedures for CLIA categorization: guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, October 2, 2017
Subject(s):: Clinical Laboratory Techniques
Device Approval -- standards
Diagnostic Test Approval -- standards
In Vitro Techniques -- standards
Reagent Kits, Diagnostic -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

12. Administrative rulemaking

Author(s):: Berry, Melissa D, author
Publication:: [Toronto, Ontario] : Thomson Reuters, 20-December-2021
Subject(s):: Health Care Reform -- legislation & jurisprudence
Health Insurance Exchanges -- legislation & jurisprudence
Insurance, Health -- legislation & jurisprudence
Legislation, Medical
COVID-19
Health Information Interoperability
Medicaid -- legislation & jurisprudence
Medicare -- legislation & jurisprudence
United States
United States. Department of Health and Human Services.
United States.

13. Administrative rulemaking

Author(s):: Berry, Melissa D., author
Publication:: [Toronto, Ontario] : Thomson Reuters, 23-December-2019
Subject(s):: Health Care Reform -- legislation & jurisprudence
Advertising -- legislation & jurisprudence
Conscientious Refusal to Treat -- legislation & jurisprudence
Contraception
Drug Costs
Emergency Medical Services -- legislation & jurisprudence
Emigrants and Immigrants -- legislation & jurisprudence
Hospital Costs
Insurance, Health, Reimbursement
Long-Term Care
Medicaid -- legislation & jurisprudence
Medicare -- legislation & jurisprudence
Politics
Taxes
Transportation of Patients -- legislation & jurisprudence
Humans
United States
United States. Department of Health and Human Services.
United States.
Centers for Medicare & Medicaid Services (U.S.)

14. Adolescent and young adult substance use: federal grants for prevention, treatment, and recovery services and for research : report to Congressional committees

Publication:: Washington, DC : United States Government Accountability Office, September 2018
Subject(s):: Financing, Government
Substance-Related Disorders -- prevention & control
Adolescent
Young Adult
United States
United States. Department of Education.
United States. Department of Health and Human Services.
United States. Department of Justice.

15. Advancement of emerging technology applications for pharmaceutical innovation and modernization

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, September 2017
Subject(s):: Biomedical Technology -- standards
Drug Industry -- standards
Inventions
Quality Assurance, Health Care
Quality Improvement
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

16. Alaska State Medicaid Fraud Control Unit: 2016 onsite review

Publication:: [Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, September 2017
Subject(s):: Fraud -- prevention & control
Medicaid
Federal Government
State Government
Humans
Alaska
United States
United States. Department of Health and Human Services.

17. Allergic rhinitis: developing drug products for treatment

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, September 2018
Subject(s):: Clinical Trials as Topic
Drug Evaluation
Rhinitis, Allergic -- drug therapy
Adrenal Cortex Hormones -- therapeutic use
Adult
Child
Drug Combinations
Research Design
Single-Blind Method
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

18. Alternative procedures for blood and blood components during the COVID-19 public health emergency

Publication:: Silver Spring, MD : Center for Biologics Evaluation and Research, April 2020
Subject(s):: Blood Donors
Blood Transfusion
Plasma
COVID-19
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

19. Amyotrophic lateral sclerosis: developing drugs for treatment

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, September 2019
Subject(s):: Amyotrophic Lateral Sclerosis -- drug therapy
Clinical Trials as Topic -- standards
Drug Development -- standards
Pharmacokinetics
Research Design -- standards
Safety
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

20. Anthrax: developing drugs for prophylaxis of inhalational anthrax

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, May 2018
Subject(s):: Anthrax -- drug therapy
Anthrax -- prevention & control
Antibiotic Prophylaxis
Clinical Trials as Topic
Drug Evaluation, Preclinical -- standards
Drugs, Investigational -- therapeutic use
Inhalation Exposure
Adult
Child
Endpoint Determination
Microbial Sensitivity Tests -- standards
Pediatrics
Product Surveillance, Postmarketing -- standards
Research Design
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

21. Antibacterial therapies for patients with an unmet medical need for the treatment of serious bacterial diseases

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, August 2017
Subject(s):: Anti-Bacterial Agents -- therapeutic use
Bacterial Infections -- drug therapy
Drug Approval
Drug Resistance, Bacterial
Investigational New Drug Application
Clinical Trials as Topic
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

22. Antibiotic resistance: more information needed to oversee use of medically important drugs in food animals : report to Congressional requesters

23. Appropriate use of voluntary consensus standards in premarket submissions for medical devices: guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, September 14, 2018
Subject(s):: Clinical Trials as Topic
Consensus
Device Approval
Equipment and Supplies -- standards
Voluntary Programs
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.

24. As funding for BPA research increased, NIEHS followed its peer review process while also exercising its discretion

Publication:: [Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, August 2017
Subject(s):: Peer Review
Phenols -- adverse effects
Research -- economics
Federal Government
Financing, Government
Humans
United States
United States. Department of Health and Human Services.
National Institutes of Health (U.S.)

25. Assessing COVID-19-related symptoms in outpatient adult and adolescent subjects in clinical trials of drugs and biological products for COVID-19 prevention or treatment

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, September 2020
Subject(s):: Clinical Trials as Topic
COVID-19 -- drug therapy
COVID-19 -- prevention & control
Outpatients
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

26. Assessing user fees under the Biosimilar User Fee Amendments of 2017

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, January 2020
Subject(s):: Biosimilar Pharmaceuticals -- economics
Drug Development -- economics
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

27. Assessing user fees under the Prescription Drug User Fee Amendments of 2017

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, May 2018
Subject(s):: Fees and Charges
Investigational New Drug Application -- economics
Prescription Drugs -- economics
Biological Products -- economics
Orphan Drug Production -- economics
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

28. Assessing user fees under the biosimilar user fee amendments of 2017

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, June 2018
Subject(s):: Biosimilar Pharmaceuticals -- economics
Fees and Charges
Investigational New Drug Application -- economics
Drug Evaluation -- economics
Parenteral Nutrition Solutions -- economics
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

29. Assessment and synthesis of selected Medicaid eligibility, enrollment, and renewal processes and systems in six states

Author(s):: Zylla, Emily, author
Au-Yeung, Caroline, author
Lukanen, Elizabeth, author
Worrall, Christina, author
Publication:: [Minneapolis, Minnesota] : State Health Access Data Assistance Center, October 19, 2018
Subject(s):: Eligibility Determination -- organization & administration
Medicaid -- statistics & numerical data
Electronic Data Processing
Federal Government
Income
Patient Navigation
State Government
Humans
United States
United States. Department of Health and Human Services.
United States.
State Children's Health Insurance Program (U.S.)

30. Associations between county-level vaccination rates and COVID-19 outcomes among Medicare beneficiaries

Author(s):: Samson, Lok Wong, author
Tarazi, Wafa, author
Orav, E. John, author
Sheingold, Steven, author
De Lew, Nancy, author
Sommers, Benjamin D., author
Publication:: Washington, D.C. : Department of Health and Human Services, Office of the Assistant Secretary for Planning and Evaluation, October 5, 2021
Subject(s):: COVID-19 -- epidemiology
COVID-19 Vaccines
Medicare
Outcome and Process Assessment, Health Care
Local Government
United States
United States. Department of Health and Human Services.

31. BCG-unresponsive nonmuscle invasive bladder cancer: developing drugs and biologics for treatment

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, February 2018
Subject(s):: Clinical Trials as Topic -- standards
Drug Evaluation -- standards
Urinary Bladder Neoplasms -- drug therapy
Biological Products -- therapeutic use
Chemistry, Pharmaceutical
Mycobacterium bovis
Research Design
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

32. Bacterial risk control strategies for blood collection establishments and transfusion services to enhance the safety and availability of platelets for transfusion

Publication:: Silver Spring, MD : Center for Biologics Evaluation and Research, September 2019
Subject(s):: Bacteriological Techniques
Blood Banks -- standards
Blood Platelets -- microbiology
Blood Preservation -- standards
Platelet Transfusion -- standards
Transfusion Reaction -- prevention & control
Product Labeling -- standards
Quality Control
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

33. Bacterial vaginosis: developing drugs for treatment

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, August 2019
Subject(s):: Clinical Trials as Topic
Drug Development
Vaginosis, Bacterial -- drug therapy
Pharmacokinetics
Research Design
Safety
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

34. Basic safety and essential performance of medical electrical equipment, medical electrical systems, and laboratory medical equipment: standards specific information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program : guidance for industry, accreditation bodies, testing laboratories, and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, September 25, 2020
Subject(s):: Accreditation
Electricity
Equipment Safety
Equipment and Supplies
Mechanical Tests
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

35. Best practices for communication between IND sponsors and FDA during drug development: guidance for industry and review staff : good review practice

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, December 2017
Subject(s):: Communication
Drug Industry
Investigational New Drug Application
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

36. Bioanalytical method validation

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, May 2018
Subject(s):: Drug Evaluation, Preclinical -- standards
Reproducibility of Results
Research Design -- standards
Validation Studies as Topic
Biomarkers
Documentation
Dried Blood Spot Testing -- standards
Investigational New Drug Application
Quality Control
Reagent Kits, Diagnostic -- standards
Sensitivity and Specificity
Specimen Handling -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

37. Biocompatibility testing of medical devices: standards specific information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program : guidance for industry, accreditation bodies, testing laboratories, and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, September 25, 2020
Subject(s):: Accreditation
Equipment and Supplies
Materials Testing -- standards
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

38. Biodefense: federal efforts to develop biological threat awareness : report to Congressional requesters

Publication:: Washington, D.C. : U.S. Government Accountability Office, October 2017
Subject(s):: Bioterrorism -- prevention & control
Civil Defense
Awareness
Biological Warfare
Data Collection
Information Dissemination
Public Health
Research
Humans
United States
United States. Department of Agriculture.
United States. Department of Defense.
United States. Department of Health and Human Services.
United States. Department of Homeland Security.
United States. Environmental Protection Agency.

39. Biological product deviation reporting for blood and plasma establishments

Publication:: Silver Spring, MD : Center for Biologics Evaluation and Research, March 2020
Subject(s):: Biological Products
Blood Banks -- standards
Mandatory Reporting
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

40. Blood glucose monitoring test systems for prescription point-of-care use: guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, September 29, 2020
Subject(s):: Blood Glucose
Equipment Safety
Point-of-Care Testing
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

41. Bone anchors: premarket notification (510(k)) submissions : guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, March 3, 2020
Subject(s):: Device Approval
Suture Anchors
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

42. Breast implants: certain labeling recommendations to improve patient communication : guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, September 29, 2020
Subject(s):: Breast Implants
Equipment Safety
Product Labeling
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

43. CDC generally met its inspection goals for the federal select agent program: however, opportunities exist to strengthen oversight

Publication:: [Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, May 2017
Subject(s):: Government Regulation
Security Measures
Toxins, Biological
Federal Government
Laboratories -- standards
Risk Assessment
Risk Management
Humans
United States
United States. Department of Health and Human Services.
Centers for Disease Control and Prevention (U.S.)

44. CMS did not detect some inappropriate claims for durable medical equipment in nursing facilities

Publication:: [Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, June 2018
Subject(s):: Durable Medical Equipment -- economics
Insurance, Health, Reimbursement
Medicare -- economics
Skilled Nursing Facilities
Home Care Services -- economics
Insurance Claim Review
Insurance Coverage
Medicaid -- economics
Nursing Homes
Humans
United States
United States. Department of Health and Human Services.
Centers for Medicare & Medicaid Services (U.S.)

45. CMS validated hospital inpatient quality reporting program data, but should use additional tools to identify gaming

Publication:: [Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, April 2017
Subject(s):: Economics, Hospital
Insurance, Health, Reimbursement
Quality Indicators, Health Care
Reimbursement, Incentive
Cross Infection
Inpatients
Mandatory Reporting
Humans
United States
United States. Department of Health and Human Services.
Centers for Medicare & Medicaid Services (U.S.)

46. COVID-19 public health emergency: general considerations for pre-IND meeting requests for COVID-19 related drugs and biological products : guidance for industry and investigators

Publication:: [Silver Spring, MD] : Center for Drug Evaluation and Research, May 2020
Subject(s):: Biological Products
COVID-19 -- drug therapy
Drug Approval
Drug Industry
Drugs, Investigational
Drug Evaluation, Preclinical
Investigational New Drug Application
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

47. COVID-19: developing drugs and biological products for treatment or prevention

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, February 2021
Subject(s):: Biological Products
COVID-19 -- drug therapy
COVID-19 -- prevention & control
Drug Industry
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

48. Calculation of potential inflation-indexed rebates for Medicare Part B drugs

Publication:: [Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, August 2017
Subject(s):: Drug Costs
Insurance, Pharmaceutical Services -- economics
Medicare Part B -- economics
Cost Control
Cost Savings
Medicaid -- economics
Humans
United States
United States. Department of Health and Human Services.

49. Cancer clinical trial eligibility criteria: brain metastases

Publication:: Silver Spring, MD : Food and Drug Administration, Oncology Center of Excellence, July 2020
Subject(s):: Brain Neoplasms
Clinical Trials as Topic
Eligibility Determination
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

50. Cancer clinical trial eligibility criteria: minimum age considerations for inclusion of pediatric patients : guidance for industry and IRBs

Publication:: Silver Spring, MD : United States Food and Drug Administration, Oncology Center of Excellence, July 2020
Subject(s):: Clinical Trials as Topic
Eligibility Determination
Neoplasms
Pediatrics
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

51. Cancer clinical trial eligibility criteria: patients with HIV, hepatitis B Virus, or hepatitis C Virus Infections

Publication:: [Silver Spring, MD] : United States Food and Drug Administration, Oncology Center of Excellence, July 2020
Subject(s):: Clinical Trials as Topic
Hepatitis B
Hepatitis C
HIV
Neoplasms
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

52. Cancer clinical trial eligibility criteria: patients with organ dysfunction or prior or concurrent malignancies

Publication:: [Silver Spring, MD] : United States Food and Drug Administration, Oncology Center of Excellence, July 2020
Subject(s):: Clinical Trials as Topic
Eligibility Determination
Heart Failure
Liver Failure
Neoplasms
Renal Insufficiency
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

53. Care provider facilities described challenges addressing mental health needs of children in HHS custody

Publication:: [Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, September 2019
Subject(s):: Child Health Services
Emigrants and Immigrants -- psychology
Mental Health Services
Refugees
Child
Health Services Accessibility
Mental Disorders -- therapy
Psychological Trauma -- therapy
Humans
United States
United States. Department of Health and Human Services.

54. Center for Devices and Radiological Health (CDRH) appeals processes: questions and answers about 517A : guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, March 27, 2020
Subject(s):: Device Approval
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.

55. Center for Devices and Radiological Health appeals processes: questions and answers about 517A : guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, Maryland] : Center for Devices and Radiological Health, September 29, 2017
Subject(s):: Device Approval -- standards
Documentation -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.

56. Centering fathers in human services programming to increase participation

Author(s):: DeLisle, Danielle, author
Selekman, Rebekah, author
Publication:: [Princeton, New Jersey] : Mathematica, October 2021
Subject(s):: Community Participation
Father-Child Relations
Fathers
Government Programs -- organization & administration
United States
United States. Department of Health and Human Services.

57. Certificates of confidentiality: guidance for sponsors, sponsor-investigators, researchers, industry, and food and drug administration staff

Publication:: Silver Spring, MD : Center for Biologics Evaluation and Research September 2020
Subject(s):: Biomedical Research
Confidentiality
Privacy
Research Subjects
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

58. Challenges appear to limit states' use of Medicaid payment suspensions

Publication:: [Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, September 2017
Subject(s):: Fraud -- prevention & control
Medicaid -- economics
State Government
Humans
United States
United States. Department of Health and Human Services.

59. Challenges remain in FDA's inspections of domestic food facilities

Publication:: [Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, September 2017
Subject(s):: Food Industry
Food Inspection
Food Safety
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

60. Challenges to public health reporting experienced by non-federal acute care hospitals: 2019

Author(s):: Richwine, Chelsea, author
Marshall, Carmelita, author
Jensen, Christian, 1833-1916, author
Patel, Vaishali, author
Publication:: Washington, DC : U.S. Department of Health and Human Services, Office of the National Coordinator for Health Information Technology, September 2021
Subject(s):: Health Information Interoperability
Hospitals
Information Dissemination
Mandatory Reporting
Public Health
Public Health Surveillance
COVID-19
Health Facility Size
State Government
United States
United States. Department of Health and Human Services.

61. Changes to existing medical software policies resulting from section 3060 of the 21st Century Cures Act: guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, September 27, 2019
Subject(s):: Equipment and Supplies -- standards
Software -- legislation & jurisprudence
Electronic Health Records
Healthy Lifestyle
Hospital Information Systems
Mobile Applications -- legislation & jurisprudence
Software -- classification
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.
United States.

62. Chemistry, manufacturing, and control (CMC) information for human gene therapy investigational new drug applications (INDs)

Publication:: Silver Spring, MD : Center for Biologics Evaluation and Research, January 2020
Subject(s):: Chemistry, Pharmaceutical
Genetic Therapy
Investigational New Drug Application
Drugs, Investigational
Quality Control
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

63. Child-resistant packaging statements in drug product labeling

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, August 2019
Subject(s):: Consumer Product Safety
Drug Labeling -- standards
Drug Packaging -- standards
Child
Nonprescription Drugs
Prescription Drugs
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

64. Chronic hepatitis C virus infection: developing direct-acting antiviral drugs for treatment

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, November 2017
Subject(s):: Antiviral Agents -- therapeutic use
Clinical Trials as Topic
Drug Evaluation, Preclinical -- standards
Drugs, Investigational -- therapeutic use
Hepatitis C, Chronic -- drug therapy
Antiviral Agents -- pharmacokinetics
Drugs, Investigational -- pharmacokinetics
Research Design -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

65. Chronic obstructive pulmonary disease: use of the St. George's Respiratory Questionnaire as a PRO assessment tool

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, March 2018
Subject(s):: Patient Outcome Assessment
Patient Reported Outcome Measures
Pulmonary Disease, Chronic Obstructive -- therapy
Surveys and Questionnaires
Clinical Trials as Topic
Outcome Assessment (Health Care)
Self-Assessment
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

66. Citizen petitions and petitions for stay of action subject to section 505(q) of the Federal Food, Drug, and Cosmetic Act

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, September 2019
Subject(s):: Drug Approval -- legislation & jurisprudence
Investigational New Drug Application -- legislation & jurisprudence
Public Health -- legislation & jurisprudence
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.

67. Civil money penalties relating to the ClinicalTrials.gov data bank: guidance for responsible parties, submitters of certain applications and submissions to FDA, and FDA staff

Publication:: Silver Spring, MD : United States Food and Drug Administration, Office of Good Clinical Practice. August 2020
Subject(s):: Clinical Trials as Topic
Databases as Topic
Data Management -- legislation & jurisprudence
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

68. Clarification of orphan designation of drugs and biologics for pediatric subpopulations of common diseases

Publication:: Silver Spring, MD : Office of Orphan Products Development, Food and Drug Administration, July 2018
Subject(s):: Drug Approval
Orphan Drug Production
Pediatrics
Adolescent
Biological Products
Child
Clinical Trials as Topic
Colitis, Ulcerative -- drug therapy
HIV Infections -- drug therapy
Infant
Prevalence
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

69. Class II special controls guideline: in vitro diagnostic devices for Bacillus spp. detection : guideline for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, April 1, 2019
Subject(s):: Bacillus
Equipment Safety
Reagent Kits, Diagnostic -- classification
Reagent Kits, Diagnostic -- standards
Bacteriophage Typing -- classification
Enzyme-Linked Immunosorbent Assay -- classification
Fluorescent Antibody Technique -- classification
Nucleic Acid Amplification Techniques -- classification
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

70. Classification and requirements for laser illuminated projectors (LIPs): (Laser Notice No. 57) : guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, May 8, 2019
Subject(s):: Equipment Safety
Lasers -- classification
Lasers -- standards
Device Approval
Lasers -- adverse effects
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

71. Classification of posterior cervical screw systems: small entity compliance guide : guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, May 4, 2020
Subject(s):: Bone Screws
Cervical Vertebrae
Classification
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

72. Classification of products as drugs and devices & additional product classification issues: final guidance : guidance for industry and FDA staff

Publication:: Silver Spring, MD : Office of Combination Products, Food and Drug Administration, September 2017
Subject(s):: Biological Products -- classification
Classification -- methods
Equipment and Supplies -- classification
Pharmaceutical Preparations -- classification
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

73. Clinical drug interaction studies: cytochrome P450 enzyme- and transporter-mediated drug interactions

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, January 2020
Subject(s):: Drug Interactions
Clinical Trials as Topic
Cytochrome P-450 Enzyme System
Drugs, Investigational
Membrane Transport Proteins
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

74. Clinical investigations for prostate tissue ablation devices: guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, July 15, 2020
Subject(s):: Clinical Studies as Topic
High-Intensity Focused Ultrasound Ablation
Prostate -- surgery
Prostatic Neoplasms -- prevention & control
Prostatic Neoplasms -- surgery
Therapies, Investigational
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

75. Clinical trial imaging endpoint process standards

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, April 2018
Subject(s):: Clinical Trials as Topic -- standards
Diagnostic Imaging -- standards
Endpoint Determination -- standards
Research Design -- standards
Observer Variation
Single-Blind Method
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

76. Colorado State Medicaid Fraud Control Unit: 2016 onsite review

Publication:: [Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, August 2017
Subject(s):: Fraud -- prevention & control
Medicaid
Federal Government
State Government
Humans
Colorado
United States
United States. Department of Health and Human Services.

77. Community-acquired bacterial pneumonia: developing drugs for treatment

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, June 2020
Subject(s):: Community-Acquired Infections
Drug Development
Pneumonia, Bacterial -- drug therapy
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

78. Comparing outcomes for dual eligible beneficiaries in integrated care: final report

Author(s):: Feng, Zhanlian, author
Wang, Feng, (College teacher in marketing) author
Gadaska, Angela, author
Knowles, Molly, author
Haber, Susan, author
Ingber, Melvin J., author
Grouverman, Valentina, author
Publication:: Washington, D.C. : U.S. Department of Health and Human Services, Office of the Assistant Secretary for Planning and Evaluation, Office of Behavioral Health, Disability, and Aging Policy, September 2021
Subject(s):: Delivery of Health Care, Integrated
Dual MEDICAID MEDICARE Eligibility
Outcome Assessment, Health Care
United States
United States. Department of Health and Human Services.

79. Competitive generic therapies

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, March 2020
Subject(s):: Drug Approval
Drugs, Generic
Investigational New Drug Application
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

80. Compliance policy for certain compounding of oral oxitriptan (5-HTP) drug products for patients with tetrahydrobiopterin (BH4) deficiency: immediately in effect guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, July 2019
Subject(s):: Drug Compounding -- standards
5-Hydroxytryptophan -- therapeutic use
Phenylketonurias -- drug therapy
Guideline Adherence
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.

81. Compliance policy for limited modifications to certain marketed tobacco products

Publication:: Silver Spring, MD : Center for Tobacco Products, November 2019
Subject(s):: Electronic Nicotine Delivery Systems -- standards
Nicotine -- adverse effects
Tobacco Products -- adverse effects
Child
Consumer Product Safety
Equipment Failure
Product Packaging
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

82. Compliance policy for required warning statements on small-packaged cigars

Publication:: Silver Spring, MD : Center for Tobacco Products, Food and Drug Administration, September 2017
Subject(s):: Product Labeling -- standards
Product Packaging -- standards
Tobacco Products -- standards
Guideline Adherence
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

83. Compliance policy for the quantity of bioavailability and bioequivalence samples retained under 21 CFR 320.38(c)

Publication:: [Silver Spring, MD] : Center for Drug Evaluation and Research, August 2020
Subject(s):: Biological Availability
Therapeutic Equivalency
Biopharmaceutics
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

84. Complicated intra-abdominal infections: developing drugs for treatment

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, May 2018
Subject(s):: Anti-Bacterial Agents -- therapeutic use
Clinical Trials as Topic
Drug Evaluation -- standards
Drugs, Investigational -- pharmacokinetics
Intraabdominal Infections -- drug therapy
Microbiological Techniques -- standards
Drug Labeling -- standards
Endpoint Determination -- standards
Research Design -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

85. Complicated urinary tract infections: developing drugs for treatment

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, June 2018
Subject(s):: Anti-Bacterial Agents -- therapeutic use
Anti-Infective Agents, Urinary -- therapeutic use
Clinical Trials as Topic -- standards
Drug Evaluation
Microbiological Techniques -- standards
Urinary Tract Infections -- drug therapy
Endpoint Determination -- standards
Research Design -- standards
Urinary Tract Infections -- complications
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

86. Compounded drug products that are essentially copies of a commercially available drug product under Section 503A of the Federal Food, Drug, and Cosmetic Act

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, January 2018
Subject(s):: Drug Compounding -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.

87. Compounded drug products that are essentially copies of approved drug products under Section 503B of the Federal Food, Drug, and Cosmetic Act

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, January 2018
Subject(s):: Drug Compounding -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.

88. Consideration of uncertainty in making benefit-risk determinations in medical device premarket approvals, de novo classifications, and humanitarian device exemptions: guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, August 30, 2019
Subject(s):: Compassionate Use Trials -- standards
Cost-Benefit Analysis
Device Approval -- standards
Equipment and Supplies -- classification
Uncertainty
Data Collection
Reagent Kits, Diagnostic
Research Design
Sample Size
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

89. Considerations for building federal data capacity for patient-centered outcomes research related to intellectual and developmental disabilities

Author(s):: Dhopeshwarkar, Rina, author
Heaney-Huls, Krysta, author
Hovey, Lauren, author
Leaphart, Desirae, author
Dullabh, Prashila, author
Publication:: Washington, D.C. : Department of Health and Human Services, Office of the Assistant Secretary for Planning and Evaluation, September 22, 2021
Subject(s):: Data Collection
Developmental Disabilities
Intellectual Disability
Patient-Centered Care
Research Design
United States
United States. Department of Health and Human Services.

90. Considerations for design, development, and analytical validation of next generation sequencing (NGS)--based in vitro diagnostics (IVDs) intended to aid in the diagnosis of suspected germline diseases: guidance for stakeholders and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, April 13, 2018
Subject(s):: Genetic Testing
Germ-Line Mutation
Diagnostic Test Approval
Reagent Kits, Diagnostic -- standards
Sequence Analysis, DNA
Genomics
Reproducibility of Results
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

91. Considerations for the development of dried plasma products intended for transfusion

Publication:: Silver Spring, MD : Center for Biologics Evaluation and Research, December 2019
Subject(s):: Blood Transfusion -- standards
Device Approval
Drug Approval
Drug Development -- standards
Plasma
Plasma -- microbiology
Product Packaging
Quality Control
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

92. Considerations for the inclusion of adolescent patients in adult oncology clinical trials

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, March 2019
Subject(s):: Clinical Trials as Topic -- ethics
Adolescent
Neoplasms -- drug therapy
Adult
Medical Oncology -- ethics
Patient Safety
Patient Selection
Pharmacokinetics
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

93. Considerations in demonstrating interchangeability with a reference product

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, May 2019
Subject(s):: Biosimilar Pharmaceuticals -- standards
Drug Substitution
Proteins -- therapeutic use
Biological Products
Clinical Trials as Topic
Research Design
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

94. Consumer antiseptic wash final rule: questions and answers : (Small Entity Compliance Guide)

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, July 2017
Subject(s):: Anti-Infective Agents, Local
Consumer Product Safety
Hand Sanitizers
Nonprescription Drugs
Anti-Bacterial Agents
Anti-Infective Agents, Local -- adverse effects
Soaps
Triclosan
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

95. Control of nitrosamine impurities in human drugs

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, February 2021
Subject(s):: Drug Contamination -- prevention & control
Nitrosamines
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

96. Conventional Foley catheters--performance criteria for safety and performance based pathway: guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, August 14, 2020
Subject(s):: Equipment Design
Equipment Safety
Urinary Catheterization
Urinary Catheters -- standards
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

97. Coordinated development of antimicrobial drugs and antimicrobial susceptibility test devices: guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, February 1, 2019
Subject(s):: Anti-Infective Agents
Device Approval
Drug Approval
Drug Development
Microbial Sensitivity Tests
Drug Industry
Biotechnology
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

98. Cutaneous electrodes for recording purposes--performance criteria for safety and performance based pathway: guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, August 14, 2020
Subject(s):: Electrodes
Equipment Design
Equipment Safety
Electrocardiography
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

99. Cytomegalovirus in transplantation: developing drugs to treat or prevent disease

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, May 2020
Subject(s):: Cytomegalovirus Infections -- drug therapy
Cytomegalovirus Infections -- prevention & control
Organ Transplantation
Stem Cell Transplantation
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

100. Data inadequacies undermine CMS's oversight of the inconsistency resolution process for the federal marketplace

Publication:: [Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, March 2017
Subject(s):: Data Collection
Eligibility Determination
Health Insurance Exchanges
Cost Sharing
Federal Government
Government Regulation
Humans
United States
United States. Department of Health and Human Services.
United States.
Centers for Medicare & Medicaid Services (U.S.)