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FDA Head Calls for Investigation Into Agency's Approval of Aducanumab (Aduhelm)

After several weeks of outcry and heated debate over the US Food and Drug Administration's (FDA) controversial approval of the Alzheimer's drug aducanumab (Aduhelm), the head of the agency is now calling for a federal investigation into its own approval proceedings.

Janet Woodcock, MD, the FDA's acting commissioner, sent a letter to the Office of the Inspector General earlier today, she announced in a tweet.

Woodcock is asking for an investigation into questionable meetings and other interactions between Biogen and FDA staff members prior to the drug's approval that "may have occurred outside of the formal correspondence process."

The letter explains that concerns around these issues "could undermine the public's confidence in the FDA's decision." Therefore, an independent investigation is needed to determine whether anything occurred that was "inconsistent with FDA policies and procedures."


Read more here : https://www.medscape.com/viewarticle/954544?src=wnl_newsalrt_210709_MSCPEDIT&uac=218819SG&impID=3496250&faf=1

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