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


Senators criticize iPLEDGE

Executive Summary

A bipartisan group of senators, including Dick Durbin (D-Ill.), Judd Gregg (R-N.H.) and Orrin Hatch (R-Utah), are calling on FDA to fix the iPLEDGE risk management plan covering Roche's Accutane and isotretinoin generics. In a letter to FDA, the senators express concern that the program increases the risks of therapy by unnecessarily causing extended use. The group also complains that iPLEDGE has caused some physicians to stop prescribing the drug. The risk management plan went into effect March 1 (1"The Pink Sheet" Feb. 20, 2006, p. 14)...

You may also be interested in...

Accutane iPLEDGE Glitches Warrant Start Up Delay, Dermatology Group Urges

Implementation of the iPLEDGE pregnancy risk management program for Roche's acne therapy Accutane and isotretinoin generics should be postponed until May 1, the American Academy of Dermatology said

QUOTED. 21 April 2021. Nicholas McQuaid.

A patient recruiter got 10 years in prison for his role in a scheme to convince seniors to get unneeded and expensive genetic tests. Nicholas McQuaid, acting assistant attorney general of the Justice Department’s Criminal Division, discussed the case.

Is The US FDA At A Tipping Point?

Wall Street is worried that a cluster of recent negative regulatory events means tougher reviews going forward. That concern is probably overdone, but a year into the COVID pandemic is a good time to take stock of how FDA is doing.




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