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In this section: Search for FDA Guidance Documents

GUIDANCE DOCUMENT

Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products; Draft Guidance for Industry December 2017

Draft

Not for implementation. Contains non-binding recommendations.

Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

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 comments should be identified with the title of the guidance.