STAT News: 8 Points to Note About Aduhelm Congressional Investigation
December 30, 2022
With the release of the US congressional report about the US Food and Drug Administration’s approval of Biogen’s ill-fated Alzheimer’s drug Aduhelm, STAT News has published and article detailing 8 points to keep in mind going forward. The first is that the agency’s officials didn’t document communications with the manufacturer as required.
According to STAT, “The FDA and Biogen formed a working group ahead of the company filing an application for Aduhelm’s approval, and over a one-year period, investigators counted 115 meetings, calls, and substantive email discussions about Aduhelm. However, the committee revealed 66 calls and substantive email exchanges that weren’t properly documented. FDA guidance says that the agency is supposed to document all “substantive” communications between the agency and drug sponsors.”
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(Source: STAT News, December 29th, 2022)
