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1591. Annual status report information and other submissions for postmarketing requirements and commitments: using forms FDA 3988 and FDA 3989 : guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, September 2023
Subject(s):: Forms as Topic
Government Regulation
Product Surveillance, Postmarketing
United States
United States.
United States.

1592. Institutional review board (IRB) review of individual patient expanded access submissions for investigational drugs and biological products: guidance for IRBs and clinical investigators

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, September 2023
Subject(s):: Biological Products
Compassionate Use Trials
Drug Industry
Drugs, Investigational
Ethics Committees, Research
Government Regulation
United States

1593. Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process": guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, September 8, 2023
Subject(s):: Biological evaluation of medical devices
Device Approval
Equipment and Supplies -- adverse effects
Government Regulation
Guidelines as Topic
United States

1594. Application of human factors engineering principles for combination products: questions and answers : guidance for industry and FDA staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, September 2023
Subject(s):: Bioengineering
Device Approval
Drug Development
Drug Industry
Ergonomics
Government Regulation
United States

1595. DSCSA standards for the interoperable exchange of information for tracing of certain human, finished, prescription drugs: guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, September 2023
Subject(s):: Drug Industry
Government Regulation
Guidelines as Topic
Information Dissemination
Legislation, Drug
Prescription Drugs -- standards
United States

1596. Nontuberculous mycobacterial pulmonary disease caused by mycobacterium avium complex: developing drugs for treatment : guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, September 2023
Subject(s):: Drug Development
Drug Industry
Government Regulation
Mycobacterium avium Complex -- pathogenicity
Mycobacterium Infections, Nontuberculous -- drug therapy
United States

1597. Enhanced drug distribution security at the package level under the Drug Supply Chain Security Act: guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, August 2023
Subject(s):: Drug Industry
Drug and Narcotic Control
Drug Packaging
Government Regulation
Security Measures
United States
United States.
United States.

1598. Considerations for the use of real-world data and real-world evidence to support regulatory decision-making for drug and biological products: guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, August 2023
Subject(s):: Biological Products
Clinical Trials as Topic
Data Analysis
Decision Making
Drug Approval
Drug Industry
Drug and Narcotic Control
Government Regulation
United States
United States.

1599. Wholesale distributor verification requirement for saleable returned drug product and dispenser verification requirements when investigating a suspect or illegitimate product: compliance policies : guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, August 2023
Subject(s):: Counterfeit Drugs
Drug Industry
Drug and Narcotic Control
Fraud
Government Regulation
Substandard Drugs
United States
United States.

1600. CBO’s analysis of the long-term budgetary outlook: presentation at the University of Michigan’s 71st Annual Economic Outlook Conference

Author(s):: Dahl, Molly W., author
Publication:: [Washington, D.C.] : Congressional Budget Office, November 16, 2023
Subject(s):: Budgets -- trends
Federal Government
Forecasting
Health Care Costs -- trends
United States

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