1. Pink Sheet
  3. >>US FDA Performance Tracker

A Break-Even Year For US FDA Advisory Committees?

 
• By Michael McCaughan

Meetings have continued to be sparse through 2021, but there will end up being nearly as many panels on withdrawing approved uses as on approving new ones.

The ledger of approval vs withdrawal advisory committees will likely be in the black for the year, but it will be close. • Source: Alamy

When the US Food & Drug Administration’s Antimicrobial Drugs Advisory Committee met 7 October to review Takeda Pharmaceutical Co. Ltd.’s antiviral maribavir, it was just the tenth time the agency has convened a panel to review a pending new drug application in 2021.

There are just two more new product reviews on FDA’s official calendar for the remainder of the year: a November...

More from US FDA Performance Tracker

More from Regulatory Trackers