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

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

31. 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.

32. 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.

33. 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.

34. 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.

35. 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.

36. 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.

37. 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.

38. Safety and performance based pathway: guidance for industry and Food and Drug Administration

Publication:: Silver Spring, MD : Center for Biologics Evaluation and Research, September 20, 2019
Subject(s):: Drug Approval
Therapeutic Equivalency
Safety
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

39. Evaluation of devices used with regenerative medicine advanced therapies

Publication:: Silver Spring, MD : Center for Biologics Evaluation and Research, February 2019
Subject(s):: Device Approval
Equipment and Supplies -- classification
Regenerative Medicine -- classification
Regenerative Medicine -- instrumentation
Biological Products -- classification
Cell- and Tissue-Based Therapy -- classification
Drug Approval
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

40. Standards development and the use of standards in regulatory submissions reviewed in the Center for Biologics Evaluation and Research

Publication:: Silver Spring, MD : Center for Biologics Evaluation and Research, March 2019
Subject(s):: Guidelines as Topic
Consensus
Device Approval
Drug Approval
Government Agencies
Voluntary Programs
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
Center for Biologics Evaluation and Research (U.S.)