Subjects: United States. Food and Drug Administration - Digital Collections - National Library of Medicine Search Results

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111. S5(R3) detection of reproductive and developmental toxicity for human pharmaceuticals

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, May 2021
Subject(s):: Drug-Related Side Effects and Adverse Reactions
Reproductive Physiological Phenomena -- drug effects
Toxicity Tests
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

112. Principles of premarket pathways for combination products: guidance for industry and FDA Staff

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, January 2022
Subject(s):: Biological Products
Device Approval
Drug Approval
Government Regulation
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

113. Technical specifications for submitting clinical trial data sets for treatment of noncirrhotic nonalcoholic steatohepatitis (NASH)

Publication:: [Silver Spring, MD] : Center for Drug Evaluation and Research, January 2022
Subject(s):: Clinical Trials as Topic
Non-alcoholic Fatty Liver Disease -- drug therapy
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

114. Principles for selecting, developing, modifying, and adapting patient-reported outcome instruments for use in medical device evaluation: guidance for industry and Food and Drug Administration staff, and other stakeholders

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, January 26, 2022
Subject(s):: Device Approval
Patient Reported Outcome Measures
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

115. Patient engagement in the design and conduct of medical device clinical studies: guidance for industry, Food and Drug Administration staff, and other stakeholders

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, January 26, 2022
Subject(s):: Clinical Studies as Topic
Device Approval
Patient Participation
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

116. Investigational COVID-19 convalescent plasma

Publication:: Silver Spring, MD : Center for Biologics Evaluation and Research, January 7, 2022
Subject(s):: COVID-19 -- therapy
Immunization, Passive
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

117. Arthroscopy pump tubing sets intended for multiple patient use - Premarket Notification (510(k)) submissions: guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, December 23, 2021
Subject(s):: Arthroscopy -- instrumentation
Device Approval
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

118. Non-clinical and clinical investigation of devices used for the treatment of benign prostatic hyperplasia (BPH): guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, December 27, 2021
Subject(s):: Device Approval
Prostatic Hyperplasia -- therapy
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

119. Development of anti-infective drug products for the pediatric population

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, December 2021
Subject(s):: Anti-Infective Agents
Drug Development
Pediatrics
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

120. CMC postapproval manufacturing changes for specified biological products to be documented in annual reports

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, December 2021
Subject(s):: Biological Products -- chemistry
Biological Products -- supply & distribution
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

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