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81. Submitting clinical trial datasets and documentation for clinical outcome assessments using Item Response Theory: guidance for industry : technical specifications document

Publication:: [Silver Spring, MD] : Center for Drug Evaluation and Research, November 2023
Subject(s):: Clinical Trials as Topic
Drug Development
Drug Industry
Government Regulation
Outcome Assessment, Health Care
United States

82. Submitting patient-reported outcome data in cancer clinical trials: guidance for industry : technical specifications document

Publication:: [Silver Spring, MD] : Center for Drug Evaluation and Research, November 2023
Subject(s):: Clinical Trials as Topic
Drug Development
Drug Industry
Government Regulation
Neoplasms -- drug therapy
Patient Reported Outcome Measures
United States

83. 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

84. 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

85. 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

86. 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

87. 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

88. 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

89. 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

90. Memorandum from William H. Foege, Centers for Disease Control to C. Everett Koop

Publication:: Produced: 4 February 1983
Subject(s):: Hepatitis B Vaccines
Guillain-Barre Syndrome
Drug Approval
Drug Industry
Archival Collection:: The C. Everett Koop Papers (Profiles in Science)

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