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

Start Over Subjects Drugs, Generic ✖

1. 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.

2. 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

3. 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.

4. 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

5. Controlled correspondence related to generic drug development

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, December 2020
Subject(s):: Correspondence as Topic
Drug Development
Drugs, Generic
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

6. 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

7. 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

8. 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

9. General principles for evaluating the abuse deterrence of generic solid oral opioid drug products

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, November 2017
Subject(s):: Abuse-Deterrent Formulations -- standards
Analgesics, Opioid -- administration & dosage
Drugs, Generic
Investigational New Drug Application
Administration, Oral
Administration, Inhalation
Clinical Trials as Topic
Drug Evaluation, Preclinical
Injections
Research Design
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

10. 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.