(MedPage Today) -- The FDA needs to strengthen guardrails to ensure its accelerated approval pathway is used appropriately, the HHS Office of Inspector General (OIG) said.
The agency should do two things, the OIG recommended in a new report: it...

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HHS Inspector General Raises Concerns Over FDA's Accelerated Approvals

The Office of the Inspector General said Tuesday that its report on the FDA’s use of accelerated approval found issues with 3 of 24 instances.

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Federal watchdog raises some concerns about the FDA’s accelerated approval program

2025-01-15 02:47:27 : 
(Bloomberg) — Drug approvals from Biogen Inc. and Sarepta Therapeutics Inc. show how U.S. drug regulators are using more tools to speed up drug approvals to address unmet needs, federal regulators said in a report. The process is flawed. 
Biogen’s Aduhelm, Sarepta’s Exondys 51 and Covis Pharma’s Makena all received quick approval from the U.S. Food and Drug Administration despite weak evidence and scrutiny, according to a …

Thelocalreport.in

Report says fast-track drug approvals for Biogen and Sarepta show gaps at FDA

beckershospitalreview.com

Watchdog flags flaws in FDA's fast-track drug approvals

The upheaval over the FDA's accelerated approval of Biogen's now-pulled Alzheimer's drug Aduhelm in 2021 led HHS' Office of Inspector General to review 24 other accelerated approvals to see if there were similar deficiencies. Sarepta' ...

Endpoints News

HHS inspector general raises concerns over three FDA accelerated approvals

A new report from HHS' Office of Inspector General raises concerns about the FDA's accelerated approval process for drugs with weak supporting evidence,

ramaonhealthcare.com

Watchdog flags flaws in FDA's fast-track drug approvals – RamaOnHealthcare

The review, which was spurred by controversy over the FDA's Aduhelm approval, recommends two main changes in agency procedures.

biopharmadive.com

Federal watchdog cites concerns with FDA’s accelerated approval process

The company announced the completion of its phase 2 study assessing SPG601 in adult men with FXS, with topline findings expected to be reported by end of the first quarter in 2025.

HHS Inspector General Raises Concerns Over FDA's Accelerated Approvals

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