Tag Archives: #coronavirus #COVID-19

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

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 , | 5 Comments

Meetings, Clinical Trials and Supply Chain Disruption from a Virus We Never Heard of Until New Year’s Eve…

The world changes quickly. A few weeks ago, I published an article on LinkedIn “Communications Challenges for Medical Manufacturers as COVID-19 Epidemic Emerges”. It was meant to outline some thinking for the potential for the disruption of medical meetings, of … Continue reading

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The Side Effects of a Coronavirus Epidemic for Pharma

There are a lot of important facts on the FDA’s Web Page set up to provide information about the novel coronoavirus (2019-nCOV) outbreak, now dubbed COVID-19. But there are three sobering statements that stand out: There are no FDA-approved diagnostics … Continue reading

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