US FDA’s Comirnaty Review By The Numbers
Executive Summary
A timeline of the review and development of the first COVID-19 vaccine to win BLA approval.
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US FDA’s Non-Cancer Accelerated Approval Drugs Get Their Own Public Databases
Accelerated Approval Program web page links to searchable databases for accelerated approvals of infectious disease products, vaccines, and other nonmalignant indications. New databases, which include products that converted to regular approval or were withdrawn, are modeled after Oncology Center of Excellence’s cancer drug databases that debuted in 2021.
GSK’s Blenrep: 15 Days From Confirmatory Trial Failure To Withdrawal Announcement
The first BCMA-targeting agent to gain approval in myeloma never became the blockbuster for which GSK had hoped, but Blenrep appears to have set a new standard for speed of voluntary withdrawal of an accelerated approval drug after a confirmatory trial failure.
Clinical Trial Diversity Would Benefit From Regulatory, Financial Incentives, Experts Say
Access to expedited regulatory pathways, marketing exclusivity and tax credits in exchange for enrolling and retaining diverse clinical trial populations could provide a ‘carrot’ to the ‘stick’ in US FDA guidance and legislative proposals; attorneys Sarah Thompson Schick and Winston Kirton also call for a re-examination of concerns about remuneration for trial participants.