Category Archives: Advisory Committee Prepapartion

FDA Advisory Committee Review of 2021

FDA has scheduled the first advisory committee meetings of 2022. One meeting of the Oncologic Drugs Advisory Committee is set for February 10 to discuss a new application for the proposed treatment of Non-Small Cell Lung Cancer (NSCLC. And a … Continue reading

Posted in Advisory Committee Prepapartion | Tagged , | Comments Off on FDA Advisory Committee Review of 2021

AdComms – Is FDA Getting Less Advice?

As more drugs are being approved, is FDA getting less advice than in the past? FDA maintains a vast network of outside advisors to provide input and counsel to the agency related to decisions on policy as well as product … Continue reading

Posted in Advisory Committee Prepapartion, FDA Image, FDA Policy | Tagged , , | Comments Off on AdComms – Is FDA Getting Less Advice?

Virtual Reality – FDA and AdComms

Vaccination has been robust. Cities are opening up. Plans are underway for back-to-school. Travel is robust. Offices are cautiously re-opening. There are multiple hallmarks that, whatever the consequences, we are going back to normal. The age of COVID-19 will likely … Continue reading

Posted in Advisory Committee Prepapartion, COVID19, Current Affairs | Tagged , , | Comments Off on Virtual Reality – FDA and AdComms

“Can You Hear Me?” – The (Hopefully) Coming Transition from Virtual Meetings

Today, FDA published notice in the Federal Register of an upcoming meeting of the Arthritis Drugs Advisory Committee that will be held May 6. The meeting will be held virtually. Last year when the pandemic reality started setting in, like … Continue reading

Posted in Advisory Committee Prepapartion, Current Affairs | Tagged , , | Comments Off on “Can You Hear Me?” – The (Hopefully) Coming Transition from Virtual Meetings

Approvals in the Crazy Year of 2020

Each year in January, it is relevant to look back on the activities of FDA during the course of the previous year and look at how it was the same or different from prior years, and to look at trends … Continue reading

Posted in Advisory Committee Prepapartion, FDA Image, FDA Policy | Tagged , | Comments Off on Approvals in the Crazy Year of 2020