FDA solves citizen petition with first-of-its-kind virtual patient meeting; diabetes group now hopes trifecta of requests will make it from Commissioner’s Office to top CDER officials.
Diabetes patients and advocacy organizations are urging the drug side of FDA to catch up to its device counterpart and look beyond hemoglobin A1c as an endpoint for diabetes products.
Diabetes advocates are also asking FDA to relax requirements for cardiovascular outcomes studies of diabetes drugs pre-approval and for the agency to develop a guidance that outlines a
The Health and Human Services secretary told a Senate appropriations subcommittee that placebo-controlled trials may not be necessary to ensure vaccine safety as the FDA released a framework requiring them for COVID-19 vaccines.
HHS released the parameters for the MFN policy, which would would apply to all single source drugs in all insurance markets, according to HHS release. Secretary Robert F. Kennedy Jr. said the department is discussing the plan with drug sponsors.
The label that Novavax's COVID-19 vaccine was slated to receive before political officials held up the approval was broader than was granted 16 May.
The FDA questioned Pfizer’s reliance on a “large, incompletely defined” subgroup of castration-resistant prostate cancer patients without known HRR gene alterations in its review of the proposed expansion of Talzenna’s first-line indication for HRR-mutated CRPC to an all-comers population.
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.
US FDA Commissioner Martin Makary’s call for placebo-controlled trials to confirm the efficacy of COVID-19 boosters is drawing a lot of criticism, but former Commissioner Robert Califf also supported the idea.
