Author Archives: Mark Senak

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

Posted in Warning Letters | Comments Off on 2020 OPDP Enforcement

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

Vaccine Development and Approval in a Time of Pandemic

Sometimes in the midst of events, perspective is elusive. Today the Food and Drug Administration will hold a meeting of the Vaccines and Related Biologics Advisory Committee (VRBAC) to consider the application for an Emergency Use Authorization (EUA) submitted by … Continue reading

Posted in COVID19, FDA, FDA Image | Tagged | Comments Off on Vaccine Development and Approval in a Time of Pandemic

COVID-19 Vaccinations – Where a Commitment to Diversity is Essential

In my last posting on preparedness for a post-vaccination world I touched on some of the questions facing employers in general – policy questions that should be considered now for the eventualities of later. But digging a little deeper, there … Continue reading

Posted in Uncategorized | Tagged | Comments Off on COVID-19 Vaccinations – Where a Commitment to Diversity is Essential