Snow days extend reviews
Due to the two-day federal government shutdown, review divisions have discretion to extend any PDUFA date coming due within 30 days of the shutdown (Jan. 25 & 26) by two days. Decisions will be made on a case-by-case basis, the agency said. Texas Biotechnology's Novastan (argatroban) is one product to have its review extended: the user fee review goal for FDA's priority review of the product for use in patients with heparin-induced thrombocytopenia syndrome was originally Feb. 16 and was extended to Feb. 18
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