Pink Sheet is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


Pre-ANDA Meeting Goals May Be Created In GDUFA II

This article was originally published in The Pink Sheet Daily

Executive Summary

Idea could help sponsors of complex generics, but will it extend to other ANDAs?


Related Content

Complex ANDAs To Be Allowed Pre-Submission Product Meetings
GDUFA II Will Include Small Business Relief, Priority ANDA Reviews
Copaxone And Complex Generics: Difficult-To-Copy Does Not Mean Impossible
FDA Uses Biosimilar Strategy For Complex Generics, Offers Pre-ANDA Meetings
GDUFA Success Depends On Industry Changes As Much As Review Improvements, FDA Says





Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts