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

Start Over Subjects Drug Approval ✖ Subjects United States. Food and Drug Administration ✖

21. Conduct of clinical trials of medical products during the COVID-19 public health emergency: guidance for industry, investigators, and institutional review boards

Publication:: [Silver Spring, MD] : Center for Drug Evaluation and Research, August 30, 2021
Subject(s):: Clinical Trials as Topic
Device Approval
Drug Approval
COVID-19
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

22. Field alert report submission: questions and answers

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, July 2021
Subject(s):: Drug Approval
Research Design
Research Report
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

23. Providing regulatory submissions in alternate electronic format

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, July 2021
Subject(s):: Biological Products
Drug Approval
Drug Development
Electronic Mail
Government Regulation
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

24. Population pharmacokinetics

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, February 2022
Subject(s):: Clinical Trials as Topic
Drug Approval
Drug Development
Drugs, Investigational
Pharmacokinetics
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

25. Pre-Launch Activities Importation Requests (PLAIR)

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, March 2022
Subject(s):: Dosage Forms -- standards
Drug Approval
Drug Development
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

26. Providing submissions in electronic format: postmarketing safety reports

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, April 2022
Subject(s):: Drug Approval
Electronic Mail
Product Surveillance, Postmarketing
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

27. Drug products, including biological products, that contain nanomaterials

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, April 2022
Subject(s):: Biological Products -- standards
Drug Approval
Drug Development
Nanostructures
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

28. Providing regulatory submissions in electronic and non-electronic format: promotional labeling and advertising materials for human prescription drugs

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, April 2022
Subject(s):: Advertising -- legislation & jurisprudence
Advertising -- standards
Drug Approval
Drug Labeling -- legislation & jurisprudence
Drug Labeling -- standards
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

29. Bioavailability studies submitted in NDAs or INDs: general considerations

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, April 2022
Subject(s):: Biological Availability
Clinical Trials as Topic
Drug Approval
Drug Evaluation
Investigational New Drug Application
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

30. Chronic hepatitis B virus infection: developing drugs for treatment

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, April 2022
Subject(s):: Drug Approval
Drug Development
Hepatitis B -- drug therapy
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration