Author Archives: Mark Senak

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

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Passport Please – An App to Verify Your Status in a World Re-Shaped by COVID-19

This week New York became the first state to make available a means for mobile digital confirmation that an individual has been vaccinated for COVID-19. Popularly known as “immunity passports” they are in fact more than that. The New York … Continue reading

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“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

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OPDP Warning and Untitled Letters – A Separation; a New Letter from OPDP

This is sort of a two-for posting. First we will look at a change in how FDA is reporting regulatory actions by OPDP on the FDA website, and second we will cover the most recent such action. OPDP Warning Letter … Continue reading

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2020 OPDP Enforcement

Last month we looked at a review of FDA press releases for last year and as one might have expected, there was an enormous spike in communications as a result of the COVID-19 pandemic. Looking now to a review of … Continue reading

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