Collections: Health Policy and Services Research / Subjects: Legislation, Drug - Digital Collections - National Library of Medicine Search Results

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21. Compounding certain ibuprofen oral suspension products under section 503B of the Federal Food, Drug, and Cosmetic Act

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, April 2023
Subject(s):: Administration, Oral
Drug Compounding -- methods
Drug Compounding -- standards
Drug Industry
Government Regulation
Ibuprofen
Legislation, Drug
Suspensions
United States
United States. Food and Drug Administration
United States.

22. Waivers, exceptions, and exemptions from the requirements of section 582 of the Federal Food, Drug, and Cosmetic Act: guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, August 2023
Subject(s):: Drug Industry
Government Regulation
Legislation, Drug
United States
United States. Food and Drug Administration
United States.

23. Delays in confirmatory trials for drug applications granted FDA’s accelerated approval raise concerns

Publication:: [Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, September 2022
Subject(s):: Drug Approval
Legislation, Drug
United States
United States. Food and Drug Administration

24. 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

25. Reformulating drug products that contain carbomers manufactured with benzene: guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, December 2023
Subject(s):: Benzene
Drug Compounding
Drug Industry
Government Regulation
Legislation, Drug
Pharmaceutical Preparations
United States

26. Direct-to-consumer prescription drug advertisements: presentation of the major statement in a clear, conspicuous, and neutral manner in advertisements in television and radio format final rule : questions and answers : guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, December 2023
Subject(s):: Direct-to-Consumer Advertising -- legislation & jurisprudence
Drug Industry
Government Regulation
Legislation, Drug
Prescription Drugs
United States

27. Real-world data: assessing registries to support regulatory decision-making for drug and biological products : guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, December 2023
Subject(s):: Biological Products
Data Collection
Decision Making
Drug Industry
Legislation, Drug
Government Regulation
Pharmaceutical Preparations
Registries
United States

28. Development of monoclonal antibody products targeting SARS-CoV-2 for emergency use authorization: guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, December 2023
Subject(s):: Antibodies, Monoclonal
COVID-19 Drug Treatment
Drug Approval
Drug Industry
Government Regulation
Legislation, Drug
SARS-CoV-2
United States

29. Registration and listing of cosmetic product facilities and products: guidance for industry

Publication:: Silver Spring, MD : Office of the Chief Scientist, December 2023
Subject(s):: Cosmetics -- legislation & jurisprudence
Drug Industry
Government Regulation
Legislation, Drug
Manufacturing and Industrial Facilities -- legislation & jurisprudence
United States