Pink Sheet is part of the Business Intelligence Division 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

Accutane Psychiatric Safety Trial Planned: Roche Prepares For Hearings

Executive Summary

Roche and FDA are in discussions about the design for a prospective study to resolve questions about a potential link between the acne drug Accutane (isotretinoin) and psychiatric side effects.
Advertisement

Related Content

Accutane Risk Management Program Will Be Subject Of FDA Committee
Roche Accutane Prescriber Registry Added To Pregnancy Prevention Program
Roche Sees Global Regulatory "Tightening," Not FDA "Slowdown"
Roche Sees Pegasys Approval Delay Until 2002, But With Broader Indication
Mylan Nebivolol Hypertension Drug Patent Protection Expected Through 2015
Roche Accutane Consent Form Requires Disclosure Of Mental Health History
FDA Plans To Require Submission Of Overseas Label Changes Under Draft Rule
FDA Plans To Require Submission Of Overseas Label Changes Under Draft Rule
10 Roche Accutane Patient Registry Anticipated By Mid 2001 - FDA
Accutane Once-Daily Version Should Have Three-Year Phase-In - FDA Cmte.
Advertisement
UsernamePublicRestriction

Register

PS038359

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