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 Intellectual Bias Policy Takes Wolfe Off Contraceptives Safety Review

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA offered Public Citizen’s Sidney Wolfe a seat at the table for discussion, but no vote. Members need to report relevant information about their conflicts in a timely manner, the agency says.

You may also be interested in...



Public Citizen: US FDA Deliberately Excluded Risk Committee From Dsuvia Panel To Get Positive Vote

Risk committee has joined nearly all opioid reviews over past few years but didn’t for AcelRx's sublingual product; Raeford Brown, the analgesic advisory committee chair who was unable to attend the meeting, voices his displeasure with the vote. 

Public Citizen’s Health Group Changes Leadership, But Wolfe Remains On Prowl

Wolfe steps down to become senior advisor but remains a vocal critic of the pharmaceutical industry and FDA, as his appearance at the Avandia advisory committee meeting demonstrated.

Oral Contraceptives Petition Seeking Ban On Third-Generation Products Denied By FDA

Public Citizen losses again as the agency says current product labeling for desogestrel-containing oral contraceptives adequately describes the risk of venous thromboembolism; FDA notes the difficulty in comparing the magnitude of risks between combination OCs.

Related Content

Topics

Latest News
UsernamePublicRestriction

Register

PS073128

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