Recent And Upcoming FDA Advisory Committee Meetings
Executive Summary
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
You may also be interested in...
Modeling Is Not a Drug Approval Pathway: Why Merck Flunked Keytruda’s TNBC Advisory Panel
Advisory panel agrees with US FDA that Merck’s pathological complete response data is not strong enough for accelerated approval in high-risk, early-stage triple-negative breast cancer patients and says modeling of expected outcomes data cannot make up for this weakness.
We Still Can’t Hear You: 11 Months Into Pandemic, Virtual US FDA Meetings Still Challenging
With J&J’s panel upcoming, it’s worth reflecting on last year’s COVID-19 vaccine advisory committee meetings. Moderna’s went a bit smoother than Pfizer’s, but hiccups still raise questions about whether agency is getting the advice it needs.
EFSA's Lower Safe Intake Level For Selenium Stands Despite Supplement Industry’s Objections
The European Food Safety Authority has rejected a request from industry association Food Supplements Europe to apply its new lower intake limit for selenium to only selenomethionine and not other forms authorized for use in supplements.