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121. Submitting documents using real-world data and real-world evidence to FDA for drug and biological products

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, September 2022
Subject(s):: Biological Products
Drug Development
Government Regulation
Pragmatic Clinical Trials as Topic
United States
United States. Food and Drug Administration

122. Tobacco products: principles for designing and conducting tobacco product perception and intention studies

Publication:: Silver Spring, MD : Center for Tobacco Products, August 2022
Subject(s):: Evaluation Studies as Topic
Government Regulation
Methods
Tobacco Products
United States
United States. Food and Drug Administration

123. Replacement reagent and instrument family policy for in vitro diagnostic devices: guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, August 17, 2022
Subject(s):: Diagnostic Test Approval
Government Regulation
Reagent Kits, Diagnostic
United States
United States. Food and Drug Administration

124. Regulatory requirements for hearing aid devices and personal sound amplification products: guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, August 17, 2022
Subject(s):: Device Approval
Government Regulation
Hearing Aids
United States
United States. Food and Drug Administration

125. Policy regarding N-acetyl-L-cysteine: guidance for industry

Publication:: College Park, MD : Center for Drug Evaluation and Research, August 2022
Subject(s):: Acetylcysteine
Drug Industry
Government Regulation
United States
United States. Food and Drug Administration

126. General clinical pharmacology considerations for neonatal studies for drugs and biological products

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, July 2022
Subject(s):: Biological Products
Clinical Studies as Topic
Drug Development
Government Regulation
Infant Health
Pharmacology, Clinical
United States
United States. Food and Drug Administration

127. Cancer clinical trial eligibility criteria: available therapy in non-curative settings

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, July 2022
Subject(s):: Clinical Trials as Topic
Government Regulation
Neoplasms -- drug therapy
United States
United States. Food and Drug Administration

128. Orange Book: questions and answers

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, July 2022
Subject(s):: Drug Approval
Drugs, Generic
Government Regulation
Therapeutic Equivalency
United States
United States. Food and Drug Administration

129. Failure to respond to an ANDA complete response letter within the regulatory timeframe

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, July 2022
Subject(s):: Correspondence as Topic
Drug Approval
Government Regulation
United States
United States. Food and Drug Administration

130. Unique device identification: Policy regarding compliance dates for class I and unclassified devices, direct marking, and Global Unique Device Identification Database requirements for certain devices : guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, July 25, 2022
Subject(s):: Databases as Topic
Equipment and Supplies
Government Regulation
Product Labeling
United States
United States. Food and Drug Administration

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