Category Archives: Approval Announcements

Impact of COVID-19 on FDA Enforcement and Approvals – Part 5 – FDA Provides Update to Shape Expectations on New Approvals

In response to written questions submitted last month regarding the potential for delays, FDA had stated that “CDER remains fully capable to continue daily activities, while responding to the public needs of the current COVID-19 outbreak.” In a subsequent blog … Continue reading

Posted in Approval Announcements, COVID19, FDA Policy | Tagged , | 1 Comment

T-Minus COVID-19 – Impact of Pandemic on New Medicine Launches

As the coronavirus pandemic began to unfold, focus on the pharmaceutical and biotech sectors was on the most immediate and apparent concerns – the impact on the supply chain for drugs that are currently in the market and on the … Continue reading

Posted in Approval Announcements, COVID19, Current Affairs, Pharma Industry Image | Comments Off on T-Minus COVID-19 – Impact of Pandemic on New Medicine Launches

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

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

Posted in Advisory Committee Prepapartion, Approval Announcements | Comments Off on Sorting it Out – FDA AdComm Review for 2019

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

Posted in Approval Announcements | Comments Off on PDUFA Dates, AdComms and Approvals – 2018 So Far