NLM Digital Collections

Search

Start Over Subjects United States ✖Remove constraint Subjects: United States Subjects United States. Department of Health and Human Services. ✖Remove constraint Subjects: United States. Department of Health and Human Services.

1. 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.)

2. 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.)

4. 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.)

6. Round 2 competitive bidding for CPAP/RAD: disrupted access unlikely for devices, inconclusive for supplies

Publication:
[Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, June 2017
Subject(s):
Competitive Bidding
Continuous Positive Airway Pressure -- economics
Continuous Positive Airway Pressure -- instrumentation
Durable Medical Equipment -- economics
Health Services Accessibility -- economics
Insurance Coverage -- economics
Insurance, Health, Reimbursement
Medicare -- economics
Respiration, Artificial -- economics
Respiration, Artificial -- instrumentation
Humans
United States
United States. Department of Health and Human Services.

8. OHRP generally conducted its compliance activities independently, but changes would strengthen its independence

Publication:
[Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, July 2017
Subject(s):
Human Experimentation -- standards
Patient Rights
Research Subjects
Ethics Committees, Research
Guideline Adherence
Human Experimentation -- ethics
Humans
United States
United States. Department of Health and Human Services.
United States. Department of Health and Human Services. Office for Human Research Protections.

9. HHS's Office of Refugee Resettlement improved coordination and outreach to promote the safety and well-being of unaccompanied alien children

Publication:
[Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, July 2017
Subject(s):
Child Welfare
Emigrants and Immigrants
Emigration and Immigration
Refugees
Child
Child Abuse -- prevention & control
Human Trafficking -- prevention & control
Safety
Humans
United States
United States. Department of Health and Human Services.
United States. Department of Homeland Security.

10. Medicare program shared savings accountable care organizations have shown potential for reducing spending and improving quality

Publication:
[Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, August 2017
Subject(s):
Accountable Care Organizations
Cost Savings
Cost Sharing
Medicare
Quality of Health Care
Cost Control
Facilities and Services Utilization -- statistics & numerical data
Fee-for-Service Plans
Health Expenditures
Quality Indicators, Health Care
Humans
United States
United States. Department of Health and Human Services.

13. 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.)

15. Medicare Part B drug payments: impact of price substitutions based on 2014 average sales prices

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

17. Drug supply chain security: wholesalers exchange most tracing information

Publication:
[Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, September 2017
Subject(s):
Pharmaceutical Preparations -- supply & distribution
Prescription Drug Diversion
Information Dissemination
Security Measures
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

22. Enhancements needed in the tracking and collection of Medicare overpayments identified by ZPICS and PSCS

Publication:
[Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, September 2017
Subject(s):
Financial Audit
Insurance, Health, Reimbursement
Medicare -- economics
Contract Services
Durable Medical Equipment -- economics
Home Care Services -- economics
Hospice Care -- economics
Information Dissemination
Humans
United States
United States. Department of Health and Human Services.
Centers for Medicare & Medicaid Services (U.S.)

23. A few states fell short in timely investigation of the most serious nursing home complaints: 2011-2015

Publication:
[Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, September 2017
Subject(s):
Nursing Homes
Quality Assurance, Health Care
Aged
Elder Abuse
State Government
Time Factors
Humans
United States
United States. Department of Health and Human Services.
Centers for Medicare & Medicaid Services (U.S.)

25. Medicare Part B drug payments: impact of price substitutions based on 2015 average sales prices

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

26. Medicare payments for clinical diagnostic laboratory tests in 2016: year 3 of baseline data

Publication:
[Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, September 2017
Subject(s):
Clinical Laboratory Techniques -- economics
Insurance, Health, Reimbursement
Medicare Part B -- economics
Prospective Payment System
Rate Setting and Review
Humans
United States
United States. Department of Health and Human Services.
Centers for Medicare & Medicaid Services (U.S.)

27. Excluding noncovered versions when setting payment for two Part B drugs would have resulted in lower drug costs for Medicare and its beneficiaries

Publication:
[Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, November 2017
Subject(s):
Drug Costs
Insurance, Pharmaceutical Services -- economics
Medicare Part B -- economics
Prospective Payment System
Abatacept -- economics
Certolizumab Pegol -- economics
Cost Savings
Injections -- economics
Self Care -- economics
Humans
United States
United States. Department of Health and Human Services.
Centers for Medicare & Medicaid Services (U.S.)
Healthcare common procedure coding system

28. Medicaid Fraud Control Units: investigation and prosecution of fraud and beneficiary abuse in Medicaid personal care services

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

29. Followup review: CMS's management of the quality payment program

Publication:
[Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, December 2017
Subject(s):
Insurance, Health, Reimbursement
Medical Informatics
Medicare Part B -- economics
Quality of Health Care -- economics
Reimbursement, Incentive
Diffusion of Innovation
Fraud -- prevention & control
Humans
United States
United States. Department of Health and Human Services.
Centers for Medicare & Medicaid Services (U.S.)

30. Potential misclassifications reported by drug manufacturers may have led to $1 billion in lost Medicaid rebates

Publication:
[Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, December 2017
Subject(s):
Drug Costs
Drug Industry -- economics
Medicaid -- economics
Pharmaceutical Preparations -- classification
Pharmaceutical Preparations -- economics
Insurance, Health, Reimbursement
Insurance, Pharmaceutical Services
Humans
United States
United States. Department of Health and Human Services.
Centers for Medicare & Medicaid Services (U.S.)

31. Entities' experiences and perceptions of reporting the theft, loss, or release of select agents or toxins to CDC

Publication:
[Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, February 2018
Subject(s):
Biohazard Release
Mandatory Reporting
Toxins, Biological
Laboratories
Organizational Culture
Safety
Theft
Humans
United States
United States. Department of Health and Human Services.
Centers for Disease Control and Prevention (U.S.)

32. Drug supply chain security: dispensers received most tracing information

Publication:
[Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, March 2018
Subject(s):
Pharmaceutical Preparations -- supply & distribution
Prescription Drug Diversion
Drug Industry
Information Dissemination
Pharmacies
Security Measures
Humans
United States
United States. Department of Health and Human Services.

34. Round two competitive bidding for oxygen: continued access for vast majority of beneficiaries

Publication:
[Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, May 2018
Subject(s):
Competitive Bidding
Durable Medical Equipment -- economics
Health Services Accessibility
Insurance, Health, Reimbursement
Medicare -- economics
Oxygen Inhalation Therapy -- economics
Fraud -- prevention & control
Humans
United States
United States. Department of Health and Human Services.

35. Round two competitive bidding for enteral nutrition: continued access for vast majority of beneficiaries

Publication:
[Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, May 2018
Subject(s):
Competitive Bidding
Durable Medical Equipment -- economics
Enteral Nutrition -- economics
Health Services Accessibility
Insurance, Health, Reimbursement
Medicare -- economics
Fraud -- prevention & control
Humans
United States
United States. Department of Health and Human Services.

36. HRSA helped health centers with elevated risks and can continue to take additional steps

Publication:
[Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, May 2018
Subject(s):
Financing, Government
Health Facilities -- economics
Medically Underserved Area
Health Services Accessibility -- economics
Quality of Health Care
Risk Management
Humans
United States
United States. Department of Health and Human Services.
United States. Health Resources and Services Administration.

38. Part D plans generally include drugs commonly used by dual eligibles: 2018

Publication:
[Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, June 2018
Subject(s):
Drug Utilization
Dual MEDICAID MEDICARE Eligibility
Formularies as Topic
Medicare Part D
Insurance Benefits
Insurance, Pharmaceutical Services
Humans
United States
United States. Department of Health and Human Services.
United States.

40. Entities generally met Federal Select Agent Program internal inspection requirements, but CDC could do more to improve effectiveness

Publication:
[Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, June 2018
Subject(s):
Biohazard Release -- prevention & control
Toxins, Biological
Guideline Adherence
Laboratories
Safety
Humans
United States
United States. Department of Health and Human Services.
Centers for Disease Control and Prevention (U.S.)

41. Opioid use in Medicare Part D remains concerning

Publication:
[Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, June 2018
Subject(s):
Analgesics, Opioid -- therapeutic use
Medicare Part D
Opioid-Related Disorders -- epidemiology
Prescription Drug Misuse
Analgesics, Opioid -- economics
Fentanyl -- adverse effects
Prescription Drug Diversion
Humans
United States
United States. Department of Health and Human Services.

42. 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.)

43. Opioids in Ohio Medicaid: review of extreme use and prescribing

Publication:
[Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, July 2018
Subject(s):
Analgesics, Opioid -- therapeutic use
Inappropriate Prescribing
Medicaid
Opioid-Related Disorders -- epidemiology
Opioid-Related Disorders -- prevention & control
Prescription Drug Misuse
Analgesics, Opioid -- administration & dosage
Humans
Ohio
United States
United States. Department of Health and Human Services.
Centers for Medicare & Medicaid Services (U.S.)

46. Medicare Part B drug payments: impact of price substitutions based on 2016 average sales prices

Publication:
[Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, August 2018
Subject(s):
Drug Costs
Insurance, Health, Reimbursement
Medicare Part B -- economics
Cost Savings
Humans
United States
United States. Department of Health and Human Services.
Centers for Medicare & Medicaid Services (U.S.)

47. Questionable billing for compounded topical drugs in Medicare Part D

Publication:
[Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, August 2018
Subject(s):
Dermatologic Agents -- economics
Dermatologic Agents -- therapeutic use
Drug Compounding -- economics
Drug Utilization -- trends
Fraud
Insurance, Health, Reimbursement
Medicare Part D -- economics
Skin Cream -- economics
Administration, Topical
Dermatologic Agents -- adverse effects
Drug Compounding -- standards
Forecasting
Health Expenditures -- trends
Insurance Coverage
Skin Cream -- adverse effects
Humans
United States
United States. Department of Health and Human Services.
Centers for Medicare & Medicaid Services (U.S.)

48. FDA should further integrate its review of cybersecurity into the premarket review process for medical devices

Publication:
[Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, September 2018
Subject(s):
Computer Security
Device Approval -- standards
Equipment and Supplies -- standards
Equipment Safety -- standards
Computer Communication Networks -- standards
Guidelines as Topic
Software -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

49. Treatment planning and medication monitoring were lacking for children in foster care receiving psychotropic medication

Publication:
[Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, September 2018
Subject(s):
Antipsychotic Agents -- therapeutic use
Foster Home Care
Medication Therapy Management
Patient Care Planning
Child
Child Health Services -- standards
Inappropriate Prescribing
Mental Disorders -- drug therapy
Practice Guidelines as Topic
State Government
Humans
United States
United States. Department of Health and Human Services.

50. Medicare payments for clinical diagnostic laboratory tests in 2017: year 4 of baseline data

Publication:
[Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, September 2018
Subject(s):
Clinical Laboratory Techniques -- economics
Insurance, Health, Reimbursement
Medicare Part B -- economics
Prospective Payment System
Humans
United States
United States. Department of Health and Human Services.
Centers for Medicare & Medicaid Services (U.S.)

54. Medicare Advantage appeal outcomes and audit findings raise concerns about service and payment denials

Publication:
[Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, September 2018
Subject(s):
Health Services Accessibility
Insurance Claim Review -- statistics & numerical data
Insurance Coverage
Insurance, Health, Reimbursement
Medicare Part C
Financial Audit
Insurance Claim Review -- economics
Managed Care Programs
Humans
United States
United States. Department of Health and Human Services.
Centers for Medicare & Medicaid Services (U.S.)

55. States follow a common framework in responding to breaches of Medicaid data

Publication:
[Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, October 2018
Subject(s):
Computer Security
Fraud -- prevention & control
Medicaid
Federal Government
Health Records, Personal
State Government
Humans
United States
United States. Department of Health and Human Services.
Centers for Medicare & Medicaid Services (U.S.)

56. Hospitals reported improved preparedness for emerging infectious diseases after the Ebola outbreak

Publication:
[Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, October 2018
Subject(s):
Communicable Disease Control
Disease Outbreaks -- prevention & control
Disease Transmission, Infectious -- prevention & control
Hemorrhagic Fever, Ebola -- epidemiology
Hospitals
Civil Defense
Emergency Medical Services
Inservice Training
Humans
United States
United States. Department of Health and Human Services.
Centers for Disease Control and Prevention (U.S.)

57. Explaining Stewart v. Azar: implications of the court's decision on Kentucky's Medicaid waiver

Author(s):
Musumeci, MaryBeth, author
Publication:
San Francisco, CA : Henry J. Kaiser Family Foundation, July 2018
Subject(s):
Eligibility Determination -- legislation & jurisprudence
Employment -- legislation & jurisprudence
Medicaid -- legislation & jurisprudence
Federal Government
Health Care Reform -- legislation & jurisprudence
State Government
Humans
Kentucky
United States
United States. Department of Health and Human Services.

58. Disparities in health and health care: five key questions and answers

Author(s):
Orgera, Kendal, author
Artiga, Samantha, author
Publication:
San Francisco, CA : Henry J. Kaiser Family Foundation, August 2018
Subject(s):
Health Status Disparities
Healthcare Disparities
Insurance Coverage -- statistics & numerical data
African Americans
Asian Americans
Chronic Disease
Dental Health Services
European Continental Ancestry Group
Facilities and Services Utilization
Federal Government
Hispanic Americans
Income
Insurance Coverage -- trends
Local Government
Medically Uninsured -- statistics & numerical data
Patient Navigation
Social Determinants of Health
State Government
Humans
United States
United States. Department of Health and Human Services.
United States.

59. Gauging the progress of the National Health Information Technology Initiative: perspectives from the field

Publication:
Oakland, Calif. : California HealthCare Foundation, c2008
Subject(s):
Diffusion of Innovation
Medical Informatics -- trends
Medical Records Systems, Computerized -- trends
Program Evaluation
Federal Government
Forecasting
Government Programs
Medical Informatics -- economics
Medical Informatics -- legislation & jurisprudence
Medical Informatics -- standards
Medical Records Systems, Computerized -- economics
Medical Records Systems, Computerized -- legislation & jurisprudence
Medical Records Systems, Computerized -- standards
Privacy
State Government
Humans
United States
United States. Department of Health and Human Services.
United States.

60. Health document submission requirements for tobacco products: (revised)

Publication:
Silver Spring, MD : Center for Tobacco Products, October 2017
Subject(s):
Documentation -- standards
Tobacco Products -- standards
Drug Approval
Health
Terminology as Topic
Tobacco Products -- adverse effects
Tobacco Products -- toxicity
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.

61. Registration and product listing for owners and operators of domestic tobacco product establishments: (revised)

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, December 2017
Subject(s):
Registries -- standards
Tobacco Products -- standards
Manufacturing and Industrial Facilities -- standards
Product Labeling -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.

62. 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.

63. Regulatory classification of pharmaceutical co-crystals

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, February 2018
Subject(s):
Chemistry, Pharmaceutical -- classification
Chemistry, Pharmaceutical -- standards
Crystallization -- classification
Investigational New Drug Application
Biological Availability
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

64. Duchenne muscular dystrophy and related dystrophinopathies: developing drugs for treatment

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, February 2018
Subject(s):
Clinical Trials as Topic -- standards
Drug Evaluation -- standards
Muscular Dystrophies -- drug therapy
Muscular Dystrophy, Duchenne -- drug therapy
Drug Labeling -- standards
Drugs, Investigational
Research Design
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

65. How to prepare a pre-request for designation (pre-RFD)

Publication:
[Silver Spring, Maryland] : Office of Combination Products, Office of the Commissioner, February 2018
Subject(s):
Equipment and Supplies -- classification
Drugs, Investigational -- classification
Investigational New Drug Application
Pharmaceutical Preparations -- classification
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

67. Q11 development and manufacture of drug substances (chemical entities and biotechnological/biological entities): questions and answers

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, February 2018
Subject(s):
Chemistry, Pharmaceutical -- standards
Pharmaceutical Preparations -- standards
Biological Products -- standards
Congresses as Topic
Drug Approval
Drug Contamination
International Cooperation
Quality Control
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

68. E6(R2) good clinical practice: integrated addendum to ICH E6(R1)

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, March 2018
Subject(s):
Clinical Trials as Topic -- ethics
Clinical Trials as Topic -- methods
Ethics Committees, Research
Informed Consent
Randomized Controlled Trials as Topic -- ethics
Randomized Controlled Trials as Topic -- methods
Research Design
Research Subjects
Humans
Europe
Japan
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

69. M7(R1) assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, March 2018
Subject(s):
Carcinogenicity Tests -- standards
Carcinogens
Chemistry, Pharmaceutical
DNA Damage -- genetics
Drug Contamination -- prevention & control
Mutagenicity Tests -- standards
Mutagens
Acrylonitrile -- toxicity
Aniline Compounds -- toxicity
Benzyl Compounds -- toxicity
Bis(Chloromethyl) Ether -- toxicity
Ethyl Chloride -- toxicity
Hydrazines -- toxicity
Hydrogen Peroxide -- toxicity
Methyl Chloride -- toxicity
Nitrobenzenes -- toxicity
No-Observed-Adverse-Effect Level
Quality Control
Toxicity Tests -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

70. E18 genomic sampling and management of genomic data

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, March 2018
Subject(s):
Data Collection -- standards
Genomics -- standards
Specimen Handling -- standards
Confidentiality
Genetic Testing
Genotyping Techniques
Information Management -- standards
Informed Consent
International Cooperation
Privacy
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

71. 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.

72. Liposome drug products: chemistry, manufacturing, and controls : human pharmacokinetics and bioavailability : and labeling documentation

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, April 2018
Subject(s):
Drug Compounding -- standards
Liposomes -- chemistry
Liposomes -- pharmacokinetics
Biological Availability
Chemistry, Pharmaceutical
Liposomes -- administration & dosage
Liposomes -- therapeutic use
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

73. E11(R1) addendum: clinical investigation of medicinal products in the pediatric population

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, April 2018
Subject(s):
Clinical Trials as Topic -- ethics
Drug Compounding -- standards
Pediatrics
Pharmaceutical Preparations
Child
Excipients
Infant
Infant, Newborn
International Cooperation
Models, Theoretical
Pharmaceutical Preparations -- administration & dosage
Taste
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

74. 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.

75. Use of public human genetic variant databases to support clinical validity for genetic and genomic-based in vitro diagnostics: guidance for stakeholders and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, April 13, 2018
Subject(s):
Databases, Genetic
Reagent Kits, Diagnostic -- standards
Reproducibility of Results
Access to Information
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

77. Q7 good manufacturing practice guidance for active pharmaceutical ingredients: questions and answers

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, April 2018
Subject(s):
Chemistry, Pharmaceutical -- standards
Pharmaceutical Preparations -- standards
Quality Control
Drug Contamination
Drug Labeling -- standards
International Cooperation
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

79. 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.

80. 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.

81. S3A guidance: note for guidance on toxicokinetics : the assessment of systemic exposure in toxicity studies : focus on microsampling : questions and answers

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, May 2018
Subject(s):
Blood Specimen Collection -- methods
Drug Evaluation, Preclinical -- methods
Pharmaceutical Preparations -- administration & dosage
Sample Size
Toxicity Tests -- methods
Toxicokinetics
Pharmacokinetics
Research Design
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

83. Establishing effectiveness for drugs intended to treat male hypogonadotropic hypogonadism attributed to nonstructural disorders

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

84. 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.

85. 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.

87. 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.

88. 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.

89. 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.

90. Medical product communications that are consistent with the FDA-required labeling: questions and answers

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, June 2018
Subject(s):
Communication
Drug Labeling -- standards
Product Labeling -- standards
Equipment and Supplies -- standards
Pharmaceutical Preparations -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

91. Drug and device manufacturer communications with payors, formulary committees, and similar entities: questions and answers : guidance for industry and review staff

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, June 2018
Subject(s):
Communication
Equipment and Supplies -- economics
Insurance, Health, Reimbursement -- economics
Pharmaceutical Preparations -- economics
Truth Disclosure
Costs and Cost Analysis
Device Approval
Drug Approval
Drug Industry
Information Dissemination
Outcome Assessment (Health Care) -- economics
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

92. Logical observation identifiers names and codes for in vitro diagnostic tests: guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Biologics Evaluation and Research, June 15, 2018
Subject(s):
Electronic Health Records
Health Information Interoperability
Logical Observation Identifiers Names and Codes
Reagent Kits, Diagnostic
Device Approval
In Vitro Techniques -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

93. S9 nonclinical evaluation for anticancer pharmaceuticals: questions and answers

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, June 2018
Subject(s):
Antineoplastic Agents -- therapeutic use
Clinical Trials as Topic
Drug Evaluation, Preclinical
Antineoplastic Agents -- toxicity
Drug Approval
Drug Contamination
Research Design
Toxicity Tests
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

94. 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.

96. Revised recommendations for reducing the risk of Zika virus transmission by blood and blood components

Publication:
Silver Spring, MD : Center for Biologics Evaluation and Research, July 2018
Subject(s):
Blood Component Transfusion
Blood Safety -- standards
Blood Transfusion
Zika Virus Infection -- blood
Zika Virus Infection -- transmission
Blood Donors
Zika Virus Infection -- epidemiology
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

98. Use of electronic health record data in clinical investigations

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, July 2018
Subject(s):
Clinical Trials as Topic
Electronic Health Records -- utilization
Health Information Interoperability
Forms and Records Control
Informed Consent
Reproducibility of Results
Single-Blind Method
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

100. 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.