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Getting a Jump on PDUFA V: Fast Start on REMS, Patient Input – And Longer Reviews

 
• By Cole Werble and Michael McCaughan

The new Prescription Drug User Fee Act Program doesn’t take effect until October 1, but FDA has been getting moving on some key elements of the program since before the final negotiations began on Capitol Hill. FDA will need to move fast to meet the many policy deadlines set by the agreement negotiated with industry.

Starting to implement a law before it is signed sounds dangerous. Just suggesting the possibility has an insidious undertone; but, in the case of some recent actions by the FDA in advance of the Prescription Drug User Fee Act reauthorization, it looks more like a sign of the wise use of the full PDUFA process to manage the agency efficiently.

In several areas, FDA has begun processes that are well within its current authority so that it will be ahead of the game when PDUFA V is signed. The agency...

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

 
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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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