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

Teratogenic Drugs Pose Little Risk To Partners Of Male Patients, FDA Panel Says

Executive Summary

There is little to no evidence that a teratogenic drug would pass from a man to his female partner at a high enough level to endanger a fetus, the Drug Safety and Risk Management Advisory Committee tells FDA.

You may also be interested in...



FDA Plans To Improve REMS Effectiveness With Guidance On Goals And Metrics

The agency cited the forthcoming guidance in response to an HHS Inspector General report that questions the effectiveness of the risk management program.

Contraceptive Data Repository For Teratogenic Drug Patients Urged By FDA Panel

An updatable web-based repository of information on contraceptives would remedy the shortcomings of the current system, where information differs across drugs and is only as current as labeling, several members of the Drug Safety and Risk Management Advisory Committee note during a meeting on teratogenic risk management.

To REMS Or Not To REMS? Erivedge Shows Division At FDA Over Oncology Risk Management

The review division and CDER senior staff supported approval of Genentech’s highly teratogenic, basal cell carcinoma treatment vismodegib without a Risk Evaluation and Mitigation Strategy, but the Division of Risk Management believed a communications plan should be carried out under a REMS for the first-in-class Hedgehog pathway inhibitor.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS055039

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