FDA finalizes the "qualification process for drug development tools." The topic won't get as much attention as Breakthrough Therapy or Accelerated Approval, but the head of the drug center thinks this is a very big deal. A COPD outcomes assessment is an early example of the process in action.
The Center for Drug Evaluation & Research publishes a lot of guidances over the course of a year. Some are announced with great fanfare, most draw little attention outside of the directly affected product category, and a few may generate more attention than FDA wished.
But on January 6, FDA finalized a guidance that CDER Director Janet Woodcock has publicly said deserves a lot more attention that it got when the draft was released in...
The Oncologic Drugs Advisory Committee will vote on the risk-benefit of UGN-102 for low-grade, intermediate-risk, non-muscle invasive bladder cancer based on data from a single-arm trial, but the FDA also seeks input on requiring randomized studies for future treatments.
A US Supreme Court ruling in favor of the agency in an e-cigarette case has implications for drugs and other medical products as the justices decided not to disturb the FDA’s ‘change in position’ authority, while also creating a complex new landscape.
Deputy FDA Commissioner Grace Graham acknowledged the importance of user fees, while also calling for restructuring. She also said part of MAHA's mission is to reexamine uses of drugs not supported by data.
