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

Start Over Subjects Drug Approval ✖ Publication Year 2022 to 2024 ✖

11. 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

12. 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

13. 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

14. 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

15. 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

16. 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

17. Electronic submission of IND safety reports: technical conformance guide

Publication:: [Silver Spring, MD] : Center for Drug Evaluation and Research, April 2022
Subject(s):: Digital Technology
Drug Approval
Investigational New Drug Application
Safety
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

18. Cover letter attachments for controlled correspondence and ANDA submissions: guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, June 2023
Subject(s):: Correspondence as Topic
Drug Approval
Drug Industry
Drugs, Generic
Government Regulation
United States
United States. Food and Drug Administration

19. Delays in confirmatory trials for drug applications granted FDA’s accelerated approval raise concerns

Publication:: [Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, September 2022
Subject(s):: Drug Approval
Legislation, Drug
United States
United States. Food and Drug Administration

20. 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.