Generics Bulletin is part 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

UsernamePublicRestriction
UsernamePublicRestriction

FDA Invites Stakeholders To Join GDUFA III Talks Virtually

Dan Leonard Has Taken Helm Of AAM Just Ahead Of User Fee Negotiations

Executive Summary

The FDA has called on public stakeholders to notify the agency of their participation in the next Generic Drug User Fee Amendments program, as it sets the agenda for improving the generic drug approval process, including for complex generics.

You may also be interested in...



What’s Next? Five Things To Look Out For In October

In October, the period during which Mylan may complete its merger with Upjohn will begin, while the FDA will begin holding monthly stakeholder meetings ahead of the third iteration of the Generic Drug User Fee Amendments program, also known as GDUFA III.

Generic Association’s New CEO Signals Focus On Communications

Dan Leonard’s communications background, in addition to his policy expertise, may prove useful for the Association for Accessible Medicines as it navigates ongoing market and public policy challenges.

FDA Reveals Details Of Shilpa’s Violations

The FDA has revealed details of its recent warning letter to Shilpa, which cites the company’s failure to adequately investigate out-of-specification results and complaints as well as to follow written procedures for complaint handling.

Topics

UsernamePublicRestriction

Register

ID1132356

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

Cancel