Subjects: Drug Approval and United States. Food and Drug Administration / Genre: Technical Report - Digital Collections - National Library of Medicine Search Results

Start Over Subjects Drug Approval ✖ Subjects United States. Food and Drug Administration ✖ Genre Technical Report ✖

1. 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

2. 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

3. Failure to respond to an ANDA complete response letter within the regulatory timeframe

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, July 2022
Subject(s):: Correspondence as Topic
Drug Approval
Government Regulation
United States
United States. Food and Drug Administration

4. Assessing the effects of food on drugs in INDs and NDAs: clinical pharmacology considerations

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, June 2022
Subject(s):: Administration, Oral
Drug Approval
Drugs, Investigational
Food-Drug Interactions
Government Regulation
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. Comparability Protocols for postapproval changes to the chemistry, manufacturing, and controls information in an NDA, ANDA, or BLA: guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, October 2022
Subject(s):: Biological Products
Drug Approval
Government Regulation
United States
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. Qualification process for drug development tools: guidance for industry and FDA staff

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, November 2020
Subject(s):: Drug Approval
Drug Development -- methods
Drug Development -- standards
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

10. Formal meetings between FDA and ANDA applicants of complex products under GDUFA

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