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

US FDA Sets Generic Approval Record, But Generic Sponsors Aren't Celebrating

Executive Summary

FDA relates new record to its plan to increase access to affordable drugs, but Association for Accessible Medicines says approvals alone will not increase competition.

You may also be interested in...



Part D Coverage Gap Discount Relief Misses Ride On Opioids Bill

Biopharma will continue to seek ways to pass legislation reducing the 70% discount in Medicare Part D coverage gap but it looks like industry's next chance will be after the November elections.

US FDA May Start Missing ANDA User Fee Goals – In Order To Speed Approvals

Agency will work past generic goal dates if approval can be achieved quickly thereafter, but now must create policy defining criteria for those situations.

US FDA's Generics Program Reaches 'Steady State' Milestone

OGD Director Uhl says program is now in balance between the number of submissions and agency review actions.

Related Content

Topics

UsernamePublicRestriction

Register

GB002428

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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