Ankylosing Spondylitis Guidance To Be Considered By FDA Cmte. In 2004
Executive Summary
FDA will convene its Arthritis Advisory Committee to consider a draft guidance on ankylosing spondylitis clinical trial design in the first quarter of 2004
You may also be interested in...
CDER Guidance Agenda 2004: Pregnancy, Pediatric Studies Are Priorities
FDA is planning several new guidances to refine recommendations for drug studies in children and pregnant women during 2004, the Center for Drug Evaluation & Research's guidance agenda for the coming year indicates
CDER Guidance Agenda 2004: Pregnancy, Pediatric Studies Are Priorities
FDA is planning several new guidances to refine recommendations for drug studies in children and pregnant women during 2004, the Center for Drug Evaluation & Research's guidance agenda for the coming year indicates
Enbrel Ankylosing Spondylitis sBLA Clears FDA Cmte.; Modifying Claim Next
Sponsors seeking a disease-modifying claim for an ankylosing spondylitis indication should assess the radiographic progression of the disease, FDA's Arthritis Advisory Committee agreed during its June 24 review of Amgen/Wyeth's Enbrel