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GUIDANCE DOCUMENT

CVM GFI #82 Development of Supplemental Applications for Approved New Animal Drugs October 2002

Final
Docket Number:
FDA-1999-N-1881
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine

On November 21, 1997, President Clinton signed into law the Food and Drug Administration (FDA) Modernization Act of 1997 (FDAMA) (Pub. L. 105-115).  Section 403 of FDAMA concerns the approval of supplemental applications for approved products.  Among other things, section 403 requires FDA to issue guidance for sponsors of supplemental new animal drug applications (NADAs) that specifies data requirements that will avoid duplication of previously submitted data by recognizing the availability of data previously submitted in support of an original application (Section 403 (b)(2)).


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-1999-N-1881.

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