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Medicare and Medicaid have spent an estimated $23.8 billion on 18 FDA accelerated approval (AA) drugs with incomplete confirmatory trials that missed their planned completion dates, the HHS Office of Inspector General (OIG) said in a new report released Friday, adding that the drugs have been “staying on the market — and being administered to patients — for years without the predicted clinical benefit being verified.” Read More
The House voted 230 to 201 on Friday to pass a continuing resolution (CR) — swiftly signed into law by President Biden — funding the federal government through Dec. 16 and reauthorizing the FDA’s user fee agreements. Read More
It’s been a long time coming, but the FDA has finally published a pair of proposed rules designed to sync the agency’s institutional review board (IRB) and informed consent requirements with the Common Rule, the regulation used by most federal agencies to guide human subjects research. Read More
One day before the end of the fiscal year, the U.S. Senate passed a continuing resolution (CR) with FDA user fee authorization attached to it, moving closer to an 11th-hour funding of about half of the agency’s budget for the next five-years. Read More
Multiple comments on the FDA’s efforts to provide guidance on how sponsors can develop patient-focused clinical outcome assessments (COA) for regulatory decision-making called for more clarity on one of the four types of COA — patient reported outcomes (PRO) — and on using digital health technology (DHT) for COA data. Read More
The Center for Biologics Evaluation and Research’s (CBER) Office of Tissues and Advanced Therapies has been renamed the Office of Therapeutic Products (OTP). Read More