Published on
May 10, 2022
- 09:00 GMT
Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA Guidance for Industry
Docket Number: FDA-2017-D-5739 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance describes an enhanced pathway for discussions between FDA and a prospective applicant preparing to submit to FDA or an applicant that …
Distribution channels:
Healthcare & Pharmaceuticals Industry
