Tag Archives: #COVID-19 #coronavirus #pharma

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

Posted on March 31, 2021 by Mark Senak

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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Vaccine Development and Approval in a Time of Pandemic

Posted on December 10, 2020 by Mark Senak

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 →

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Impact of COVID-19 on Regulatory Enforcement and Approvals – Part 2

Posted on March 26, 2020 by Mark Senak

Earlier this month I published a blog posting that raised questions related to the potential for disruption of approvals in the wake of FDA actions to limit inspections due to the COVID-19 pandemic. Subsequently I had the opportunity to pose … Continue reading →

Posted in Advisory Committee Prepapartion, Approval Announcements, Current Affairs, FDA Policy | Tagged , | 14 Comments

FDA Guidance on Clinical Trials During COVID-19 Pandemic

Posted on March 20, 2020 by Mark Senak

Much attention has been paid to the impact of the COVID-19 pandemic on the supply chain for medicines we rely on, but there has been less focus on the impact of medicines yet to come. The advancements in cancer care … Continue reading →

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