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GUIDANCE DOCUMENT

CVM GFI #227 Chemistry, Manufacturing, and Controls (CMC) Technical Section Filing Strategies September 2024

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

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Submit Comments Online

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

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

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.  There are several mechanisms to receive input from the Center for Veterinary Medicine (CVM) prior to submission of the CMC technical section, as well as various approaches to submitting the CMC technical section itself.  For review efficiency, CVM prefers that full CMC information be provided in a single technical section submission.  However, there may be instances when submission of the individual components of the technical section (drug product, drug substance, and facility sterile process validation (SPV) information for sterile drug products) could reduce the overall time to complete a technical section, and therefore drug approval.  This guidance describes the options for soliciting early input from CVM and the process for submission of components of the CMC technical section.

Questions?

Contact Point
Heather Longstaff
Center for Veterinary Medicine
Food and Drug Administration
7500 Standish Place
Rockville, MD 20855
Heather.Longstaff@fda.hhs.gov
240-402-0651
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