The review, which was spurred by controversy over the FDA's Aduhelm approval, recommends two main changes in agency ...
On January 6, the U.S. Food and Drug Administration (“FDA” or the “Agency”) released a draft guidance titled “Accelerated Approval and ...
The Office of Inspector General reviewed the FDA’s use of accelerated approval for 24 drugs, ultimately finding issues with ...
The FDA established its accelerated approval program in 1992 to allow drugs to reach the market quickly for life-threatening ...
An OIG report zeroed in on what it said were three particularly problematic accelerated approvals: Biogen’s Aduhelm, ...
A report from the U.S. FDA's Office of Inspector General is calling into question the thoroughness of the agency's ...
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 ...
Life in the Fast Lane: FDA Issues New Draft Guidance for Accelerated Approval of Drugs and Biologics
2 The pathway provides an opportunity for sponsors to obtain new drug approvals more quickly than under the traditional approval process. For an accelerated approval to be granted, the sponsor ...
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.
Disc Medicine has finalized the design of the confirmatory trial for its rare blood disorder drug candidate, adding a ...
An FDA advisory committee may have ruled in elamipretide’s favor back in October, but it looks like Stealth BioTherapeutics ...
The conversion of Calquence’s accelerated approval in mantle cell lymphoma comes a day before the drug was listed among the ...
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