Califf: PDUFA Funds Will Run Dry In November, Congress Needs To Act

FDA’s prescription drug user fee program will run out of funding about five weeks into fiscal 2023 -- early November -- if Congress does not pass legislation to reauthorize the agency’s drug, medical device and biosimilars user fee programs before they expire at the end of September, FDA Commissioner Robert Califf wrote in a memo to FDA staff Friday (July 29). Congress needs to act quickly to reauthorize the programs so the agency can avoid sending layoff notices, he added...