Published on
May 10, 2022
- 09:09 GMT
Post-Complete Response Letter Clarification Teleconferences Between FDA and ANDA Applicants Under GDUFA Guidance for Industry
Docket Number: FDA-2017-D-5928 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research his guidance provides recommendations to industry on post-complete response letter (CRL) teleconferences (post-CRL clarification teleconferences) …
Distribution channels:
Healthcare & Pharmaceuticals Industry
