Subjects: Drugs, Generic and Drug Approval - Digital Collections - National Library of Medicine Search Results

Start Over Subjects Drugs, Generic ✖ Subjects Drug Approval ✖

1. Generic Drug User Fee Amendments of 2012: questions and answers related to self-identification of facilities, review of generic drug submissions, and inspections and compliance

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, July 2017
Subject(s):: Drug Approval
Drug Industry -- standards
Drugs, Generic
Guideline Adherence
Investigational New Drug Application
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

2. 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.

3. Failure to respond to an ANDA complete response letter within the regulatory timeframe: guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, December 2022
Subject(s):: Drug Approval
Drugs, Generic
Government Regulation
United States
United States. Food and Drug Administration

4. Orange Book: questions and answers

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, July 2022
Subject(s):: Drug Approval
Drugs, Generic
Government Regulation
Therapeutic Equivalency
United States
United States. Food and Drug Administration

5. Competitive generic therapies: guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, October 2022
Subject(s):: Drug Approval
Drugs, Generic
Government Regulation
Therapeutic Equivalency
United States
United States. Food and Drug Administration

6. Formal meetings between FDA and ANDA applicants of complex products under GDUFA: guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, October 2022
Subject(s):: Drug Approval
Drugs, Generic
Government Regulation
Group Processes
United States
United States. Food and Drug Administration

7. 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.

8. Referencing approved drug products in ANDA submissions

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

9. Referencing approved drug products in ANDA submissions

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

10. ANDAs for certain highly purified synthetic peptide drug products that refer to listed drugs of rDNA origin

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, May 2021
Subject(s):: Chemistry Techniques, Synthetic
DNA, Ribosomal
Drug Approval
Drugs, Generic
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration