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Excuses, Excuses: How ‘Delayed’ Confirmatory Trials Are Explained By FDA

 
• By Michael McCaughan

US FDA currently reports about two dozen Accelerated Approval having ‘delays’ in the confirmatory trials. COVID is one factor in some – and the agency also appears to be clearing out some of the others.

Excuses magnifying glass
• Source: Alamy

During a Reagan-Udall Foundation meeting tied to the 30th anniversary of the US Food & Drug Administration’s Accelerated Approval pathway, earlier this month, agency officials came armed with data to help shape the narrative around the ongoing debate over potential reforms to the program.

The data help, in part, to counter the argument that there are countless products that gain approval using the accelerated pathway but for which confirmatory clinical benefit is never demonstrated....

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More from Post-Marketing Regulation & Studies

Novavax’s COVID-19 Vaccine Label Narrowed After Political Officials Intervened

 
• By Sarah Karlin-Smith

The label that Novavax's COVID-19 vaccine was slated to receive before political officials held up the approval was broader than was granted 16 May.

Opioid Safety: US FDA Hears Mixed Messages On Adding Posmarketing Studies To Labeling

 
• By Sue Sutter

Some advisory committee members said adding quantitative data on misuse, abuse, opioid use disorder and overdose to labeling would be helpful, but others worried the two epidemiological studies were not sufficiently generalizable to a broader population.

Updated: Makary Backs New Novavax COVID-19 Trial, Political Officials Take Over Product Review

 
• By Sarah Karlin-Smith

In an unusual move, Tracy Beth Høeg, a special assistant to FDA Commissioner Martin Makary, is leading the continued negotiations on Novavax’s delayed COVID-19 vaccine approval.

Pink Sheet Podcast: More US FDA Departures, Makary On Combined AE Database, ‘Conditional’ Approval

 
• By Derrick Gingery, Sarah Karlin-Smith, and Sue Sutter

Pink Sheet reporter and editors discuss the most recent senior staff departures at the FDA and their impact on the agency, as well as Commissioner Martin Makary’s plans for a new approval pathway and a combined adverse event database as outlined in an interview with a podcast host.

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