- Docket Number:
- FDA-1998-D-0021
- Issued by:
-
Guidance Issuing Office
Center for Drug Evaluation and Research
This guidance provides revised recommendations on what chemistry, manufacturing, and controls (CMC) information to include regarding the reporting, identification, and qualification of impurities in drug substances produced by chemical synthesis when submitting:
- Original abbreviated new drug applications (ANDAs)
- Drug master files (DMFs) including type II DMFs
- ANDA supplements for changes in the synthesis or processing of a drug substance
The guidance also provides recommendations for establishing acceptance criteria for impurities in drug substances.
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-1998-D-0021.
