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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.

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.

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.

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

Publication:
Washington, D.C. : U.S. Government Accountability Office, March 2017
Subject(s):
Anti-Bacterial Agents -- adverse effects
Anti-Bacterial Agents -- therapeutic use
Bacterial Infections -- drug therapy
Drug Resistance, Bacterial
Drug Resistance, Microbial
Food -- adverse effects
Food Inspection
Food Safety
Foodborne Diseases -- microbiology
Veterinary Drugs -- adverse effects
Veterinary Drugs -- therapeutic use
Bacterial Infections -- epidemiology
Cattle
Disease Outbreaks -- prevention & control
Foodborne Diseases -- epidemiology
Poultry
Swine
World health
Humans
Canada
Denmark
Netherlands
United States
United States. Department of Agriculture.
United States. Department of Health and Human Services.

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.

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.

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.

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.

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.