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

The REMS Report Card: FDA Using New Tools For One-Third Of New Drugs In First Six Months

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

FDA has used its new authority to impose a Risk Evaluation and Mitigation Strategy on roughly one-third of all new molecular entities approved since the REMS provisions of the FDA Amendments Act took effect at the end of March.

You may also be interested in...



Cymbalta Pregnancy Risk Fit FDA's New Power To Mandate Post-Market Study

FDA's application of its new ability to require - as opposed to request - post-marketing studies under the FDA Amendments Act is on display in the review of a fibromyalgia claim for Lilly's Cymbalta (duloxetine)

Cymbalta Pregnancy Risk Fit FDA's New Power To Mandate Post-Market Study

FDA's application of its new ability to require - as opposed to request - post-marketing studies under the FDA Amendments Act is on display in the review of a fibromyalgia claim for Lilly's Cymbalta (duloxetine)

FDA Amendments Act’s One-Year Anniversary: For Better Or Worse

At the one-year anniversary of the FDA Amendments Act, the agency's record is mixed in meeting its increased responsibilities and authorities the law requires

Related Content

Topics

UsernamePublicRestriction

Register

PS003992

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