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OIG Accelerated Approval Report Spotlights Financial Costs Ahead Of Congressional Debate

 
• By Sarah Karlin-Smith

First OIG report on FDA’s accelerated approval program as part of Aduhelm-spurred review doesn’t break new ground but will likely bring new wave of focus on the costs incurred to the government when drug companies fail to complete confirmatory trials in a timely manner just as reform advocates are hoping to muster enough attention on the topic to get legislative change this year.

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New OIG accelerated approval report could impact chances of Congressional reform this year. • Source: Shutterstock

Advocates of accelerated approval reform were given new ammunition with the 29 September release of a US Department of Health and Human Services Office of Inspector General report on delays in confirmatory trials for the drugs.

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FDA Leadership Shuffle Continues: Lowell Zeta Returns As OPDP, OGD Leaders Depart

 
• By Sue Sutter and Derrick Gingery

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US FDA Commissioner Makary Wants To Combine Adverse Event Reporting Systems

 
• By Sarah Karlin-Smith

In discussing FDA’s adverse event monitoring, Makary also seemed to falsely imply the agency did not fully investigate the myocarditis signal with COVID-19 vaccines.

US FDA User Fee Collection Safe In Preliminary Trump 2026 Budget Plan

 
• By Cathy Kelly

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