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

First Generic Approvals Decline For Fourth Straight Year At US FDA

Executive Summary

Blemish in otherwise record-setting performance could simply be a result of coalescing variables, but it robs the agency of an easy pricing message.

You may also be interested in...



Drug Pricing Bill May Make Six-Month ANDA Review Slower Than Eight-Month Review

Legislation would create a potential second priority review pathway for generics, as well as another priority review voucher program, but may not be as enticing as GDUFA II proposal.

ANDA Backlog: FDA Climbs The Mountain, Will Need To Climb It Again

Agency has acted on 84% of generic applications pending when user fee program launched, but most actions were 'complete response' letters, which do not reduce review workload.

Review Voucher Program For Rare Pediatric Diseases Should Not Be Reauthorized, US FDA Says

More time is needed to gauge whether the US Food and Drug Administration's rare pediatric disease priority review voucher program has actually encouraged the development of new treatments, the Government Accountability Office believes. The FDA, however, isn't interested in giving the incentive program any more time to try to prove itself.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

GB002107

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