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

FDA/IoM “Uncertainty” Conference Adds Uncertainty to Biogen Growth Plans For Tysabri

This article was originally published in RPM Report

Executive Summary

An FDA/Institute of Medicine workshop on characterizing and communicating the uncertainty inherent in risk/benefit decisions touched on an important topic for every sponsor. But two “case studies” included points a very particular interest to Biogen Idec, and to sponsors in the COPD class.

You may also be interested in...



Reopening The LABA Class: FDA Shepherds Breo Through Committee For Asthma

A “safety focused” advisory committee is never something a sponsor looks forward to. But in the case of FDA’s review of GSK’s new Breo Ellipta asthma inhaler, the outcome was generally positive. In this case, FDA seems more concerned that too much emphasis on safety is steering development aware from an area of significant medical need.

FDAAA Fading? REMS Use Continues To Decline As Drug Safety Law Matures

FDA’s use of REMS continues to fall to almost undetectable levels, with the agency using the safety tools just a handful of times in the sixth full year of the program. REMS are now very much the exception and not the rule for new products – but still a very important exception.

“Grades” for FDA Approvals: When Academics Weigh in on Regulation

Physicians and patients need a better understanding of the quality of clinical trial design and data used to approve drugs, say researchers in a study published in JAMA. That led them to suggest a grading system to add another layer of information to FDA approvals, adding another academic suggestion for elaborating, explaining and embellishing FDA action.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS079679

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