Advisory Committees, Drug Reviews, and CRL’s. Oh My!

Q&A – September 8, 2025

This week’s questions:Is Secretary Kennedy at risk of losing his job?What is Kenvue? Doesn’t J&J make Tylenol?How realistic is it to dramatically shorten product review cycles? ———Q:  Is Secretary Kennedy at risk of losing his job? A: Many...
Advisory Committees, Drug Reviews, and CRL’s. Oh My!

Q&A – September 1, 2025

This week’s questions:What’s at stake when a CDC director won’t sign off on the Administration’s vaccine policies, is fired, and several senior center leaders resign? What happens next at CDC?What are the possible impacts of the CDC situation on FDA and...
Advisory Committees, Drug Reviews, and CRL’s. Oh My!

Q&A – August 25, 2025

———This week’s questions:Did your column on MAHA intend to deliver a specific message to journalists and lead advocacy groups? What is the most critical FDA issue in September? What are some FDA issues that are simmering and will eventually surface?...