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May 7, 2020

Contract Manufacturing Arrangements for Drugs: Quality Agreements Guidance for Industry

Docket Number: FDA-2013-D-0558 Issued by: Guidance Issuing Office Center for Veterinary Medicine Center for Drug Evaluation and Research Center for Biologics Evaluation and Research This guidance […]
May 7, 2020

Content and Format for Geriatric Labeling

Docket Number: FDA-1998-D-0037 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research In a final rule published in […]
May 7, 2020

Consumer Antiseptic Wash Final Rule Questions and Answers

Docket Number: FDA-2017-D-3906 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance is intended to help small businesses better understand and comply […]
May 7, 2020

Considerations When Transferring Clinical Investigation Oversight to Another IRB

Docket Number: FDA-2011-D-0835 Issued by: Guidance Issuing Office Office of the Commissioner, Office of Clinical Policy and Programs, Office of Clinical Policy, Office of Good Clinical […]
May 7, 2020

Over-the-Counter (OTC) | Nonprescription Drugs

On March 27, 2020, the President signed the Over-the-Counter Monograph Safety, Innovation, and Reform Act into law. This act is intended to modernize the process by […]
May 7, 2020

Alive By Nature, Inc. – 607435 – 05/06/2020

Product: Drugs DATE:             May 6, 2020 RE:                 Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) This is to advise you that […]
May 7, 2020

GlutaGenic – 607271 – 05/06/2020

Product: Drugs Date:                May 6, 2020 RE:                  Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) This is to advise you that the […]
May 6, 2020

CPG Sec. 448.100 Reconditioning of New Drugs Which Do Not Have Approved NDAs/ANDAs

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5)) If unable to submit comments online, please mail written […]
May 6, 2020

CPG Sec. 446.100 Regulatory Action Regarding Approved New Drugs and Antibiotic Drug Products Subjected to Additional Processing or other Manipulations

Docket Number: None found Issued by: Guidance Issuing Office Center for Drug Evaluation and Research BACKGROUND: FDA is issuing this policy guide to describe the circumstances […]
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