Author Archives: Mark Senak

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

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

The Definition of “Fully Vaccinated” Needs to Change

The COVID-19 pandemic is a rapidly changing landscape. We are long gone from the days of being threatened by a rampant Alpha virus to having several successive variants. It now appears that the very fast-spreading Omicron may become dominant over … Continue reading

Posted in COVID19 | Tagged , , | Comments Off on The Definition of “Fully Vaccinated” Needs to Change

The Once and Future FDA Commissioner

In what has been a glacially paced nomination process, the Biden Administration announced on November 12 that it would, in fact, be nominating Dr. Robert Califf to return to his role as FDA Commissioner. Acting Comissioner Janet Woodcock indicated in … Continue reading

Posted in FDA Image | Tagged , | Comments Off on The Once and Future FDA Commissioner

Headache for the Next Commissioner – FDA’s Reputation Crisis

Recently it was reported that the President Biden appears ready to nominate former FDA Commissioner Robert Califf to boomerang back and head the agency for a second time. If so, he returns to very different circumstances than when he left … Continue reading

Posted in FDA Image | Tagged , , | Comments Off on Headache for the Next Commissioner – FDA’s Reputation Crisis