RIASTAP Lead Page

STN# 125317Proper Name: Fibrinogen Concentrate (Human)Tradename: RIASTAPManufacturer: CSL Behring GmbHIndication:Treatment of of acute bleeding episodes in pediatric and adult patients with congenital fibrinogen deficiency, including afibrinogenemia and...

Guidance for Industry

Docket Number: FDA-2023-D-2204 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Formal Dispute Resolution and...
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