- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Drug Evaluation and Research
This guidance describes an enhanced pathway for discussions between FDA and a prospective 17 applicant preparing to submit or an applicant that has submitted an abbreviated new drug 18 application (ANDA) for a complex product to FDA as defined in this guidance. Specifically, 19 this guidance provides information on requesting and conducting product development meetings, 20 pre-submission meetings, and mid-review-cycle meetings with FDA.
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-2017-D-5739.