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


Bill To Speed ANDA Approvals Gets Cool Reception From Industry, US FDA

Executive Summary

At House hearing, FDA and AAM highlight logistical challenges of legislation's six-month ANDA review goal and potential to put GDUFA II agreement at risk.


Related Content

REMS Could Block ANDAs With 'Legitimate Business Justification' In Senate Bill
FDA User Fee Hearing Hijacked By US Health Care Reform Arguments
PDUFA VI: Pediatrics Group Seeks Earlier And Faster Studies
Obamacare Repeal May Be Delaying User Fee Bill, Rep. DeGette Says
Drug Pricing Bill May Make Six-Month ANDA Review Slower Than Eight-Month Review
US FDA’s Foreign Inspection Agenda: Visit The 1,000 Facilities It’s Never Seen
Generic Drug First-Cycle Approval Rates Lagging Under GDUFA I
Complex ANDAs To Be Allowed Pre-Submission Product Meetings
ANDAs Can Get Priority, Eight-Month Reviews Under User Fee Deal
Buying Time: Industry Sacrifices Early To Gain Later With PDUFA V Review Model





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