Fractionated Plasma Products

The following products are regulated as Fractionated Plasma Products:Fractionated Plasma Products With Supporting DocumentsAlbuminAlpha-1 Proteinase InhibitorAntihemophilic Factor (Recombinant)Antihemophilic Factor (Recombinant), Glycopegylated-Exei Antihemophilic...

CDER Heparin Importation

Historically, serious injuries and deaths have been associated with the use of contaminated heparin. FDA expects all imported heparin sodium lots to be compliant with the latest US Pharmacopeia (USP) specifications and FDA’s regulatory standards to ensure the safety...

Environmental Impact Review at CDER

The National Environmental Policy Act of 1969 (NEPA) requires all Federal agencies to assess the environmental impact of their actions and to ensure that the interested and affected public is informed of the environmental analyses. The Food and Drug Administration...
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