ANDA Submissions — Refuse to Receive for Lack of Justification of Impurity Limits Guidance for Industry September 2016
- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Drug Evaluation and Research
This guidance is intended to assist applicants preparing to submit to the Food and Drug Administration (FDA) original abbreviated new drug applications (ANDAs) and prior approval supplements (PASs) to ANDAs for which the applicant is seeking approval of a new strength of the drug product. The guidance highlights deficiencies in relation to information about impurities that may cause FDA to refuse to receive (RTR) an ANDA. An RTR decision indicates that FDA determined that an ANDA is not sufficiently complete to permit a substantive review.
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:
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-1292.