GUIDANCE DOCUMENT
Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products; Draft Guidance for Industry December 2017
Not for implementation. Contains non-binding recommendations.
- Docket Number:
- FDA-1995-D-0288
- Issued by:
-
Guidance Issuing OfficeCenter for Drug Evaluation and Research
1
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-1995-D-0288.