Subjects: Drug Approval / Languages: English - Digital Collections - National Library of Medicine Search Results

Start Over Subjects Drug Approval ✖ Languages English ✖

91. 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.

92. Benefit-risk assessment for new drug and biological products: guidance for industry

Publication:: Silver Spring, MD : Center for Biologics Evaluation and Research, October 2023
Subject(s):: Biological Products
Drug Approval
Drug Industry
Drugs, Investigational
Government Regulation
Pharmaceutical Preparations
Risk Assessment
United States

93. Real-time oncology review (RTOR): guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, November 2023
Subject(s):: Biological Products
Drug Approval
Drug Industry
Drugs, Investigational
Government Regulation
Neoplasms -- drug therapy
United States

94. 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

95. 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)

96. Letter from C. Everett Koop to Diane L. Schweber

Publication:: Produced: 9 December 1982
Subject(s):: Hepatitis B Vaccines
Guillain-Barre Syndrome
Drug Approval
Drug Industry
Archival Collection:: The C. Everett Koop Papers (Profiles in Science)

97. Memorandum from Arthur Hull Hayes Jr., Food and Drug Administration to C. Everett Koop

Publication:: Produced: 6 January 1983
Subject(s):: Hepatitis B Vaccines
Guillain-Barre Syndrome
Drug Approval
Drug Industry
Archival Collection:: The C. Everett Koop Papers (Profiles in Science)

98. Memorandum from C. Everett Koop to William H. Foege, Centers for Disease Control and Arthur Hull Hayes Jr., Food and Drug Administration

Publication:: Produced: 9 December 1982
Subject(s):: Drug Approval
Drug Industry
Guillain-Barre Syndrome
Hepatitis B Vaccines
Archival Collection:: The C. Everett Koop Papers (Profiles in Science)

99. Letter from Diane L. Schweber to C. Everett Koop

Publication:: Produced: 22 November 1982
Subject(s):: Drug Approval
Drug Industry
Guillain-Barre Syndrome
Hepatitis B Vaccines
Archival Collection:: The C. Everett Koop Papers (Profiles in Science)

100. National women's health action at the F.D.A. Sept. 20, 1994

Publication:: [United States : s.n.], 1994
Subject(s):: Women's Health
Drug Industry
Drugs, Investigational
Drug Approval
United States. Food and Drug Administration.

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