Category Archives: Current Affairs

Impact of COVID-19 on Regulatory Enforcement and Approvals – Part 3 – FDA Adds Resources to Facilitate COVID-19 Research

With the COVID-19 impact making itself apparent on a daily basis as the numbers climb and organizations respond, the effects on the pharma and biotech sector also shifts. Yesterday FDA announced a new concentration of agency assets to be focused … Continue reading

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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 , | 14 Comments

Principles for COVID-19 Healthcare Communications – 1 Keep it Simple, Keep it Organized

On February 21 I published a piece on LinkedIn – Communications Considerations for Medical Manufacturers as the COVID-19 Epidemic Emerges – that provided an overview of some of the communications considerations for pharma, biotech and device manufacturers related to the … Continue reading

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Impact of COVID-19 on Regulatory Enforcement and Approvals

The impacts of the COVID-19 pandemic bring change shifts the status quo on a daily basis with both breadth and depth. Everything we as individuals and as a society would normally do is undergoing change. FDA regulatory oversight is one … Continue reading

Posted in Current Affairs, FDA Image, FDA Policy | 1 Comment

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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