Category Archives: FDA Policy

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

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

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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

FDA Takes A Number of Actions to Enhance the Market for Biosimilars – A Process Not an Event

There is a policy interest in driving the biosimilar market. Among other reasons, increasing the number of generic drugs and biosimilars on the market addresses another policy priority – having an impact on the high cost of medicine. The approval … Continue reading

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2020 Vision – Notable FDA Actions During 2019

Happy New Year! It is 2020 – the year of clear vision. Let’s look back for a bit as we plunge forward. FDA is a giant agency where a lot happens. Narrowing down the actions of significance is therefore a … Continue reading

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