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Browsing Tag
Protocols
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FDA broke own protocols in approving Biogen Alzheimer’s drug, congressional report says
The U.S. Food and Drug Administration failed to adhere to its own guidance and internal practices during the approval process for Biogen’s Alzheimer’s drug Aduhelm, which was “rife with irregularities,” a congressional report showed on Thursday.The FDA’s interactions with Biogen were “atypical” and did not follow the agency’s documentation protocol, according to a staff report on
Hypertension Protocols Curb Racial Bias in Therapeutic Inertia
Therapeutic inertia regarding intensification of blood pressure treatment has been shown to be more of an issue in Black patients, but this was not the case in the SPRINT trial, which involved a strict standardized approach to blood pressure management, a new analysis shows. "Overall, we found that therapeutic inertia was similar in different races…