Subjects: Government Regulation / Genre: Guideline - Digital Collections - National Library of Medicine Search Results

Start Over Subjects Government Regulation ✖ Genre Guideline ✖

111. Assessing the credibility of computational modeling and simulation in medical device submissions: guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, November 17, 2023
Subject(s):: Computer Simulation
Device Approval
Government Regulation
United States

112. Q5A(R2): viral safety evaluation of biotechnology products derived from cell lines of human or animal origin : guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, January 2024
Subject(s):: Biotechnology
Cell Line
Drug Industry
Government Regulation
Safety
Virus Diseases
United States

113. 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

114. 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

115. 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

116. Digital health technologies for remote data acquisition in clinical investigations: guidance for industry, investigators, and other stakeholders

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, December 2023
Subject(s):: Data Collection
Digital Health
Equipment Design
Equipment Safety
Government Regulation
Medical Device Legislation
Remote Sensing Technology -- standards
United States

117. Rare diseases: considerations for the development of drugs and biological products : guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, December 2023
Subject(s):: Biological Products
Drug Development
Drug Industry
Government Regulation
Rare Diseases -- drug therapy
United States

118. 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

119. 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

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