An Institute for Clinical and Economic Review white paper states the potential benefits and challenges of several policy changes that could strengthen the accelerated approval pathway.
AdvaMed says it supports FDA efforts to expand exemptions from premarket notification for some Class 2 devices.
An Institute for Clinical and Economic Review white paper states the potential benefits and challenges of several policy changes that could strengthen the accelerated approval pathway.
AdvaMed says it supports FDA efforts to expand exemptions from premarket notification for some Class 2 devices.
The Trump administration nominates former deputy surgeon general Erica Schwartz to be CDC director, and taps FDA principal deputy commissioner Sara Brenner to be the public health advisor to HHS secretary Robert F. Kennedy Jr.
Eli Lilly says it will seek expanded FDA approval by the end of the quarter for its obesity drug Foundayo (orforglipron) as a treatment for diabetes, following positive topline results from its Phase 3 ACHIEVE-4 trial.
