Category Archives: Approval Announcements

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

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Sorting it Out – FDA AdComm Review for 2019

Has FDA been holding enough AdComms? There have been a large number of drugs approved in the past year, but there has not been a corresponding increase in the number of advisory committees staged by FDA. Late in 2019, I … Continue reading

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PDUFA Dates, AdComms and Approvals – 2018 So Far

There would seem to be a momentum for new approvals brought on by a number of circumstances, not the least of which is the fact that last year saw a record number (47) of approvals for new molecular entities (NMEs), … Continue reading

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The Convergence of Digital Health, Devices and Pharma

There has been a huge push in policy circles to speed innovation in medicine which is manifest in several initiatives, including most notably the 21st Century Cures Act implementation. But it would be a mistake to assess the quickening pace … Continue reading

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The White House on FDA Approval Burden – Is There a There There?

In his remarks to a joint session of Congress delivered this week, President Trump expressed the point of view that the “slow and burdensome approval process at the Food and Drug Administration keeps too many advances… from reaching people in … Continue reading

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