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11. 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

12. Good manufacturing practice considerations for responding to COVID-19 infection in employees in drug and biological products manufacturing

Publication:: [Silver Spring, MD] : Center for Drug Evaluation and Research, June 2020
Subject(s):: Biological Products
COVID-19 -- prevention & control
Drug Industry
Manufacturing and Industrial Facilities
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

13. 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.

14. COVID-19: developing drugs and biological products for treatment or prevention

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, February 2021
Subject(s):: Biological Products
COVID-19 -- drug therapy
COVID-19 -- prevention & control
Drug Industry
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

15. 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.

16. Wholesale distributor verification requirement for saleable returned drug product and dispenser verification requirements when investigating a suspect or illegitimate product: compliance policies

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, October 2020
Subject(s):: Drug Industry
Drug and Narcotic Control
Pharmaceutical Preparations
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

17. Resuming normal drug and biologics manufacturing operations during the COVID-19 public health emergency

Publication:: [Silver Spring, MD] : Center for Drug Evaluation and Research, September 2020
Subject(s):: Biological Products
Drug Industry
Manufacturing and Industrial Facilities
COVID-19
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

18. 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.

19. 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

20. 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

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