The marketability and even the approvability of the first-in-class JAK inhibitor for treatment of rheumatoid arthritis may hinge on whether it can be shown to offer patients a structural benefit. FDA briefing documents for the May 9 advisory committee review show issues with those findings.
FDA’s Arthritis Advisory Committee will be tasked with determining whether a novel treatment for rheumatoid arthritis can be approved despite inconclusive radiographic data, when it meets May 9 to review Pfizer Inc.’s Janus kinase inhibitor tofacitinib.
This would be the first JAK inhibitor for RA, with the requested indication being for treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an...
The remarks from the new CBER director suggest Prasad will not be involved in most product-specific decisions.
A UK research team has used artificial intelligence to find new treatments for cancer using existing US Food and Drug Administration-approved medicines that are not normally not used for the disease.
The US Medicare Patient Advisory Commission worries that Medicare prescription drug market trends may cause the stand-alone plan portion of the program to “wither away,” which could take the traditional fee-for-service side of Medicare with it.
The Clinical Trials Access Collaborative (CTAC) will build on a pilot program's work to bolster community-based clinical research infrastructure so "anyone who wants to participate in clinical trials can and do it closer to home,” CEO Tesheia Harris said in an interview.
CBER's Nicole Verdun wants rare disease sponsors with stalled treatments to circle back because the FDA's evolved thinking on clinical trial designs may offer another opportunity for cast away products.
The White House requested $6.8bn for the FDA, down 3.9% from the current funding level, but does not propose any legislative changes. In previous years, the agency used the budget process to seek statutory fixes specific to generic drugs and shortages.
The reductions across medical product programs in the agency’s budget request include hundreds of positions funded by user fees, which may foreshadow its upcoming user fee restructuring strategy.
