GUIDANCE DOCUMENT
CVM GFI #271 Reporting and Mitigating Animal Drug Shortages during the COVID-19 Public Health Emergency May 2020
- Docket Number:
- FDA-2020-D-1140
- Issued by:
-
Guidance Issuing OfficeCenter for Veterinary Medicine
This guidance is intended to remain in effect until November 7, 2023, unless superseded by a revised final guidance before that date. For further information, refer to 88 FR 15417, March 13, 2023.
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?
- CVM
- Center for Veterinary Medicine
Food and Drug Administration
7500 Standish Pl, HFV-1
Rockville, MD 20855
- AskCVM@fda.hhs.gov
- (240) 402-7002