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. ✖

31. Generic drugs: FDA should make public its plans to issue and revise guidance on nonbiological complex drugs : report to Congressional requesters

Publication:: Washington, DC : United States Government Accountability Office, December 2017
Subject(s):: Drug Approval
Drugs, Generic
Therapeutic Equivalency
Chemistry, Pharmaceutical
Doxorubicin
Drug Development
Enoxaparin
Glatiramer Acetate
Gluconates
Propofol
Humans
United States
United States. Food and Drug Administration.

32. Risk evaluation and mitigation strategies: modifications and revisions

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, June 2020
Subject(s):: Drug Approval
Drug Industry
Drug Labeling
Risk Evaluation and Mitigation
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

33. COVID-19 public health emergency: general considerations for pre-IND meeting requests for COVID-19 related drugs and biological products : guidance for industry and investigators

Publication:: [Silver Spring, MD] : Center for Drug Evaluation and Research, May 2020
Subject(s):: Biological Products
COVID-19 -- drug therapy
Drug Approval
Drug Industry
Drugs, Investigational
Drug Evaluation, Preclinical
Investigational New Drug Application
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

34. ANDA submissions: amendments and requests for final approval to tentatively approved ANDAs

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, September 2020
Subject(s):: Drug Approval
Drug Industry
Drugs, Generic
Therapeutic Equivalency
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

35. FDA oversight

Author(s):: White, Robert S, author
Publication:: [Toronto, Ontario] : Thomson Reuters, 20-December-2021
Subject(s):: Drug Approval
Drug Therapy
Drugs, Investigational
Government Regulation
Illicit Drugs
United States
United States. Food and Drug Administration.

36. Providing regulatory submissions in electronic format: certain human pharmaceutical product applications and related submissions using the eCTD specifications

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, February 2020
Subject(s):: Drug Approval
Electronic Data Processing
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

37. The "deemed to be a license" provision of the BPCI Act: questions and answers

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, March 2020
Subject(s):: Biological Products
Drug Approval
Licensure
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

38. Competitive generic therapies

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, March 2020
Subject(s):: Drug Approval
Drugs, Generic
Investigational New Drug Application
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

39. FDA oversight

Author(s):: White, Robert S., author
Publication:: [Toronto, Ontario] : Thomson Reuters, 23-December-2019
Subject(s):: Drug Approval
Drug Therapy
Government Regulation
Orphan Drug Production
Rare Diseases -- drug therapy
Humans
United States
United States. Food and Drug Administration.

40. Coordinated development of antimicrobial drugs and antimicrobial susceptibility test devices: guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, February 1, 2019
Subject(s):: Anti-Infective Agents
Device Approval
Drug Approval
Drug Development
Microbial Sensitivity Tests
Drug Industry
Biotechnology
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.