Pink Sheet 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

Advisory Committee Will Cause FDA To Miss PDUFA Date For Auxilium’s Xiaflex

This article was originally published in The Pink Sheet Daily

Executive Summary

Delay may be sign of FDAAA-produced drag on approvals; firm says no new data needed.

You may also be interested in...



Auxilium Submits Xiaflex BLA, Scans Wide-Open Orphan Market

Niche indications in Dupuytren’s and Peyronie’s could pay off for Auxilium and partner Pfizer.

Advisory Committee Policy Allows Members With Financial Conflicts To Vote

FDA advisory committee participants with personal financial conflicts of interest may fully participate in committee meetings, according to the agency's new conflict of interest policy. The final guidance eliminates the draft provision that financial conflicts of any sort preclude an opportunity for panelists to vote

Rx Misbranding Penalties Should Be Stronger To Stop Counterfeiting, FDA Says

Industry also seems supportive of the idea, while Pew touts the power of the power of track-and-trace as a deterrent.

Topics

UsernamePublicRestriction

Register

OM005224

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