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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 […]
May 6, 2020

CPG Sec. 444.100 Recovery of Investigational New Drugs from Clinical Investigators

Docket Number: None found Issued by: Guidance Issuing Office Center for Drug Evaluation and Research POLICY: We will regard the retrieval of investigational new drugs from […]
May 6, 2020

CPG Sec. 442.100 New Drugs – Export

Docket Number: None found Issued by: Guidance Issuing Office Center for Drug Evaluation and Research BACKGROUND: The question has been raised as to whether or not […]
May 6, 2020

CPG Sec. 440.100 Marketed New Drugs Without Approved NDAs and 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 […]
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