The partial government shutdown could soon become the longest shutdown in history, and biotech firms that have submitted regulatory filings are facing greater uncertainty about their future plans. More than 40 percent of FDA workers and thousands at the SEC are furloughed, and FDA Commissioner Scott Gottlieb is resorting to Twitter to post updates about how his agency is using its fast-dwindling funds. Here’s a roundup of how the partial government shutdown is affecting the FDA.
On Tuesday, Gottlieb wrote that the agency is shifting user fees away from pre-market drug reviews to post-market safety surveillance. These fees, paid by companies,… Read more »
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