Federal health officials want an investigation of their own decisions.
The acting Food and Drug Administration commissioner has called for a probe into her own agency’s approval of Biogen’s …
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Federal health officials want an investigation of their own decisions.
The acting Food and Drug Administration commissioner has called for a probe into her own agency’s approval of Biogen’s new Alzheimer’s disease drug.
Dr. Janet Woodcock publicly shared a copy of her letter to the Office of the Inspector General requesting an investigation into Aduhelm’s approval.
“There continue to be concerns raised regarding contacts between representatives from Biogen and FDA during the review process, including some that may have occurred outside of the formal process,” Woodcock wrote.
The FDA in June approved aducanumab (now called Aduhelm). That set off a wave of excitement among healthcare providers caring for people with dementia and families in desperate need of new treatment for their loved ones.
But that didn’t stop the criticism of the clinical development process.
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