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

Avandia Concerns Highlight Need To Change Diabetes Approval Standards

Executive Summary

FDA should forgo use of glycemic control as a surrogate endpoint for clinical trials supporting the approval of type 2 diabetes therapies, Clifford Rosen said following the advisory committee review of GlaxoSmithKline's Avandia

You may also be interested in...



FDA Casts Wide Net For Advice on Avandia

Agency increases number of voting members for the meeting of the Endocrinologic and Metabolic and Drug Safety and Risk Management Advisory Committees to 33, up 10 from 2007. Half of the committee's voting members also participated in the first review of rosiglitazone's postmarketing safety.

Diabetes Therapies Need Cardiovascular Safety Data For Approval, Panel Says

Sponsors of new type 2 diabetes therapies should be required to provide clinical data that can exclude an unacceptable cardiovascular risk prior to approval, FDA's Endocrinologic and Metabolic Drugs Advisory Committee concluded at a July 1-2 meeting

Diabetes Therapies Need Cardiovascular Safety Data For Approval, Panel Says

Sponsors of new type 2 diabetes therapies should be required to provide clinical data that can exclude an unacceptable cardiovascular risk prior to approval, FDA's Endocrinologic and Metabolic Drugs Advisory Committee concluded at a July 1-2 meeting

Related Content

UsernamePublicRestriction

Register

PS048663

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