Scrip 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


OA Structural Progression Effect Size Of 50% Is "High Hurdle," PhRMA Says

Executive Summary

FDA's proposal that an osteoarthritis "delay in structural progression" claim be supported by a greater than 50% slowing of joint space narrowing is "too high a hurdle given the state of OA science," the Pharmaceutical Research & Manufacturers of America said in Sept. 14 comments on FDA's draft OA guidance.

You may also be interested in...

US FDA’s Non-Guidance On Osteoarthritis Drugs: Starting Over On Structural Claims

Agency essentially ruling out use of structural endpoints to support disease progression claims for osteoarthritis drugs in new draft guidance.

Osteoarthritis Claim Should Require Both Knee And Hip Data - Arthritis Cmte.

FDA should require osteoarthritis compounds to be studied in both the knee and hip before granting approval for an overall osteoarthritis claim, FDA's Arthritis Advisory Committee said July 21.

Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011



Ask The Analyst

Please Note: Click here for more information on the Ask the Analyst service.

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