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

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...



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.

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

UsernamePublicRestriction

Register

PS062717

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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