Category Archives: FDA Policy

What They Said 2021 – An Overview of FDA Press Statements

Each year we look back to take stock of how the agency has been communicating in the course of the previous year and assess how that might compare to years gone by. In fact from year to year, there is … Continue reading

Posted in FDA Image, FDA Policy | Tagged , , | Comments Off on What They Said 2021 – An Overview of FDA Press Statements

FDA OPDP Look Back at 2021 – The Yawning Gap

Once again it was a quiet year with respect to the FDA’s Office of Prescription Drug Programs (OPDP). As noted in the past, there are two primary means for understanding the agency’s latest thinking with respect to promotional communications from … Continue reading

Posted in DTC Advertising, FDA, FDA Policy | Tagged , , | Comments Off on FDA OPDP Look Back at 2021 – The Yawning Gap

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?

What They Said – Overview of FDA Press Releases for 2020

Well. They said a lot. A lot more than ever, as one might expect. This past year, FDA issued a whopping 420 press releases, more so by far than any year previously. COVID certainly made a big impact – a … Continue reading

Posted in Current Affairs, FDA Image, FDA Policy | Comments Off on What They Said – Overview of FDA Press Releases for 2020

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