Government Shutdown Affecting FDA Drug Approvals

Government Shutdown Affecting FDA Drug Approvals

October 16th, 2013 // 6:43 pm @

With the federal government shutdown in its second week, FDA is seeing delays in the approvals of new drugs.  The FDA shutdown is starting to delay PDUFA dates for firms that are looking to get near term FDA approval. FDA panel reviews for new drugs that are under regulatory review also are getting delayed.

Markets have their eye on some upcoming approvals that they were expecting to see okayed by FDA. One is Gildead, and that company was expecting a December approval for sofosbuvir, which could be a key breakthrough drug. Sofosbuvir could be a cure for some of the most difficult hepatitis C cases.


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