Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

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

Executive Summary

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.

You may also be interested in...



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

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.

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

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.

Osteoarthritis Structure Claim May Need Phase IV Clinical Data

Osteoarthritis agents could be eligible for a "slowing of structural deterioration" claim based on x-ray data and a commitment to do Phase IV studies measuring clinical impact on pain and function, members of FDA's Arthritis Advisory Committee agreed Feb. 20.

Latest Headlines
See All
UsernamePublicRestriction

Register

PS034563

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