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 Approves "Unprecedented" Risk Management Program For Accutane

This article was originally published in The Pink Sheet Daily

Executive Summary

Wholesalers, pharmacists, prescribers and patients will have added responsibility under the iPLEDGE program.

You may also be interested in...



US FDA Asks Manufacturers To Fix Disruption In Isotretinoin REMS

The agency offers ‘regulatory flexibility’ for certain requirements of the iPLEDGE REMS for the acne drug if manufacturers address delays in implementing the modified program.

REMS Refinement: Does iPLEDGE’s Evolution Have Lessons For Opioids?

The Drug Safety and Risk Management and Dermatologic and Ophthalmic Drugs Advisory Committees will assess the risk management program Dec. 1 for lessons about implementing REMS containing elements to assure safe use and selecting assessment metrics.

Accutane iPLEDGE Debut On Track Despite Calls For Delay

FDA confirmed that it would not delay the March 1 implementation of the isotretinoin risk management program.

Related Content

Topics

Latest News
See All
UsernamePublicRestriction

Register

PS062717

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