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

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1. Format and content of a REMS document: guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, January 2023
Subject(s):: Biological Products
Consumer Product Safety -- legislation & jurisprudence
Drug Industry
Government Regulation
Risk Evaluation and Mitigation
United States
United States. Food and Drug Administration

2. Q3D(R2) elemental impurities

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, September 2022
Subject(s):: Drug Contamination
Drug Industry
Elements
Government Regulation
Pharmaceutical Preparations -- standards
United States
United States. Food and Drug Administration

3. Policy regarding N-acetyl-L-cysteine: guidance for industry

Publication:: College Park, MD : Center for Drug Evaluation and Research, August 2022
Subject(s):: Acetylcysteine
Drug Industry
Government Regulation
United States
United States. Food and Drug Administration

4. Review timelines for applicant responses to complete response letters when a facility assessment is needed during the COVID-19 public health emergency

Publication:: [Silver Spring, MD] : Center for Drug Evaluation and Research, December 2020
Subject(s):: Correspondence as Topic
Drug Approval
Drug Industry
Facility Regulation and Control
COVID-19
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

5. Remote interactive evaluations of drug manufacturing and bioresearch monitoring facilities during the COVID-19 public health emergency

Publication:: [Silver Spring, MD] : Center for Drug Evaluation and Research, April 2021
Subject(s):: Consumer Product Safety
Drug Industry
Pharmaceutical Research
COVID-19
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

6. Manufacturing, supply chain, and drug and biological product inspections during COVID-19 public health emergency: questions and answers

Publication:: [Silver Spring, MD] : Center for Drug Evaluation and Research, May 17, 2021
Subject(s):: Biological Products
COVID-19
Drug Industry
Quality Control
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

7. Product identifiers under the Drug Supply Chain Security Act: questions and answers

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, June 2021
Subject(s):: Drug Industry
Drug Labeling
Government Regulation
Security Measures
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

8. Drug Supply Chain Security Act implementation: identification of suspect product and notification

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, June 2021
Subject(s):: Drug Industry
Drug and Narcotic Control
Security Measures
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

9. S11 nonclinical safety testing in support of development of pediatric pharmaceuticals

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, May 2021
Subject(s):: Drug Compounding
Drug Industry
Pediatrics
Pharmaceutical Preparations
Quality Control
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

10. Q12 technical and regulatory considerations for pharmaceutical product lifecycle management: annexes

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, May 2021
Subject(s):: Drug Industry
Quality Control
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration