Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

FDA Communication On Missed Deadlines Can Help Avoid Drug Review Limbo

Executive Summary

Providing a new target decision date in tandem with missing a user fee review deadline would help FDA restore credibility and predictability to the review process, former FDA official Bruce Burlington suggests

You may also be interested in...



FDA’s Rollover Reviews: Missed Deadlines Could Inflate 2009 Approval Tally

FDA is heading into 2009 with at least a dozen missed review deadlines held over from 2008 - potentially setting up the agency and industry for what could be an unusually higher number of drug and biologic approvals this year

FDA’s Rollover Reviews: Missed Deadlines Could Inflate 2009 Approval Tally

FDA is heading into 2009 with at least a dozen missed review deadlines held over from 2008 - potentially setting up the agency and industry for what could be an unusually higher number of drug and biologic approvals this year

U.S. FDA Offers Up Revised PDUFA Date In June For Takeda’s Alogliptin

U.S. FDA has set a new action date of June 26, 2009 for Takeda's dipeptidyl peptidase IV inhibitor alogliptin, after missing the original user fee deadline of Oct. 27, the company announced Dec. 24

Related Content

Latest Headlines
See All
UsernamePublicRestriction

Register

PS050465

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