Offering a unique peak behind the curtain at data that US FDA is generally prohibited from disclosing and that companies typically choose to keep secret, an agency analysis of two decades worth of refuse-to-file letters found the decisions can add a year and a half to a drug’s approval timeline.
US Food and Drug Administration refuse-to-file letters are generally issued for “substantive” deficiencies such as missing information needed to evaluate a product’s quality, safety, and efficacy, a new agency-led analysis of 103 refuse-to-file letters issued between 2008 and 2017 found.
The letters, which are issued when the agency determines a drug application is not complete enough for a full assessment, identify “foundational issues in drug review,” the study authors, led...
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.
