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The FDA has launched an external review to find out what the agency can do to better support the appropriate use of opioid analgesics in the U.S. Read More
The European Medicines Agency’s (EMA) safety committee last week recommended adding a warning to the product information for three types of drug products: terlipressin, Imbruvica and combinations of codeine with ibuprofen. Read More
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