Author Archives: Mark Senak

OPDP Issues First Regulatory Action Letter of 2022

FDA’s Office of Prescription Drug Promotion (OPDP) issued the first regulatory action letter for 2022. This one has some notable characteristics. As has been frequently noted, enforcement actions by OPDP have diminished considerably over the years. Another characteristic of recent … Continue reading

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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

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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

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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

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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

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