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GUIDANCE DOCUMENT

CVM GFI #271 Reporting and Mitigating Animal Drug Shortages during the COVID-19 Public Health Emergency May 2020

Final
Docket Number:
FDA-2020-D-1140
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine

FDA has been closely monitoring the animal drug supply chain for supply disruptions or shortages in the United States during the COVID-19 pandemic.  FDA is issuing this guidance to assist sponsors in providing FDA timely, informative notifications about changes in the production of animal drugs that will, in turn, help the Agency in its efforts to prevent or mitigate shortages of these products. 


Submit Comments

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 comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2020-D-1140.

Questions?

Contact Point
CVM
Center for Veterinary Medicine
Food and Drug Administration
7500 Standish Pl, HFV-1
Rockville, MD 20855
AskCVM@fda.hhs.gov
(240) 402-7002
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