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GUIDANCE DOCUMENT

CVM GFI #227 Two-Phased Chemistry, Manufacturing, and Controls (CMC) Technical Sections September 2015

Final

This guidance is being distributed for comment purposes only.

Docket Number:
FDA-2014-D-1492
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine

This guidance provides recommendations to sponsors submitting chemistry, manufacturing, and controls (CMC) data submissions. For review efficiency, the Center for Veterinary Medicine (CVM) prefers that CMC information be submitted in a single technical section. However, there may be instances when a two-phased technical submission process is more beneficial to improve the overall time to drug approval. Sponsors may submit the phased CMC technical section as a single technical section or a two-phased technical section. This guidance describes the use of the two-phased technical section submission process.

This guidance does not provide recommendations on the specific CMC information that should be submitted to comply with 21 CFR 514.1(b)(4) and (5). A sponsor should consider all relevant FDA guidance documents for recommendations on the information that should be submitted to support drug approval.


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-2014-D-1492.

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