Author Archives: Mark Senak

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

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

Posted in Business/Industry News, Crisis Communications, Current Affairs, Useful Resources | Leave a comment

FDA Guidance on Clinical Trials During COVID-19 Pandemic

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

Posted in Clinical Trials, FDA Policy | Tagged | Leave a comment

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

OPDP Issues First Letter of the Year

Hey! 2009 called. They want their Warning Letter back! Last week FDA’s Office of Prescription Drug Promotion (OPDP) posted the first letter issued for 2020 that was sent in February for the most common violation of all – related to … Continue reading

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