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GUIDANCE DOCUMENT

CVM GFI #234 Question-Based Review for the Chemistry, Manufacturing, and Controls Technical Section of Animal Drug Applications December 2016

Final

CVM GFI #234 Question-Based Review for the Chemistry, Manufacturing, and Controls Technical Section of Animal Drug Applications

Docket Number:
FDA-2016-D-0620
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine

Applicants must submit information on chemistry, manufacturing, and controls (CMC) to support the approval of new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) or the conditional approval of applications for conditional approval (CNADAs). The Center for Veterinary Medicine (CVM) reviews the CMC information for new animal drugs to ensure that applicants have methods and controls in place for manufacturing, processing, and packaging that are adequate for assuring and preserving the identity, strength, quality, and purity of the new animal drug and, in the case of a generic drug, to ensure that it is equivalent to the reference listed new animal drug (RLNAD). In order to improve the process for submission and review of CMC information for animal drugs, CVM has developed a series of questions that focus on the critical scientific and regulatory issues and pharmaceutical attributes essential for ensuring the quality of new animal drug substances and products. Termed Question-based Review (QbR), these questions provide a general framework for original CMC submissions to investigational new animal drug (INAD) files, generic investigational new animal drug (JINAD) files, NADAs, ANADAs, CNADAs, and veterinary master files (VMFs).


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:

Division of Dockets Management (HFA- 305)
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-2016-D-0620.

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