Government watchdog recommends tweaks to FDA accelerated approval program
The FDA established its accelerated approval program in 1992 to allow drugs to reach the market quickly for life-threatening conditions for which there is no alternative treatment. The approval then is contingent upon a confirmatory trial. But the FDA has had difficulty enforcing its post-marketing requirements.
HHS Inspector General Raises Concerns Over FDA's Accelerated Approvals
Of the 24 drugs, three approvals deviated from the others -- aducanumab; the synthetic hormone hydroxyprogesterone caproate (HPC; Makena), which was approved in 2011 to reduce the risk of recurrent preterm birth; and the Duchenne muscular dystrophy treatment eteplirsen (Exondys 51).
Federal watchdog cites concerns with FDA’s accelerated approval process
The review, which was spurred by controversy over the FDA's Aduhelm approval, recommends two main changes in agency procedures.
Federal watchdog raises some concerns about the FDA’s accelerated approval program
The Office of Inspector General reviewed the FDA’s use of accelerated approval for 24 drugs, ultimately finding issues with the process for three of them.
OIG Recommends Changes in FDA Accelerated Approval After Flagging Concerns With Aduhelm, Other Drugs
The OIG recommended that the FDA define factors that would trigger an application's review by an agency council, which the agency disagreed with.
Sarepta, Biogen drugs with accelerated approval under fire in FDA report
A report from the U.S. FDA's Office of Inspector General is calling into question the thoroughness of the agency's accelerated approval process, and is using treatments from Sarepta Therapeutics (NASDAQ:SRPT) and Biogen (NASDAQ:BIIB) as examples.
Watchdog flags flaws in FDA's fast-track drug approvals
The OIG report points to gaps in documentation and decision-making transparency, particularly in the case of Aduhelm, where FDA records indicated only 13 meetings with Biogen, but congressional investigations revealed at least 40. Some meeting summaries were also found to be incomplete, according to Bloomberg .
STAT2d
Could inhaling xenon gas help treat Alzheimer’s? A new mouse study suggests it might
The gas xenon, like the other noble, or inert, gases, is known for doing very little. The class of elements, because of its ...
Inhaling this gas could help treat Alzheimer's disease, study suggests
Scientists have discovered that inhaling xenon gas can activate brain immune cells to break down Alzheimer's-related plaques ...
pharmaphorum3d
Exit Aduhelm, enter lecanemab. Biogen and Eisai have another go
Here we go again. With Aduhelm largely sidelined, Biogen and Eisai are hoping for a better fortunes with their next Alzheimer's disease therapy lecanemab, which is now fully filed with the FDA.
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Inspector General Questions FDA’s Accelerated Approval for Biogen, Sarepta Drugs
An OIG report zeroed in on what it said were three particularly problematic accelerated approvals: Biogen’s Aduhelm, ...