The guidance was outlined in a blog post by Janet Woodcock, director of the FDA’s center for drug evaluation and research, and Karen Midthum, director of the FDA’s center for biologics evaluation and research.
he Food and Drug Administration last week announced approval for Obizur for the treatment of bleeding episodes in adults with acquired hemophilia A.
The Food and Drug Administration recently announced the availability of the “Purple Book,” which lists biological products in much the same way that the "Orange Book" lists pharmaceuticals.
The Food and Drug Administration has approved a drug that reverses the effects of anticoagulant drugs in patients who have suffered acute major bleeding, the agency said.
The Food and Drug Administraiton has approved a drug for replacing clotting proteins in the blood for conditions in which patients have too little of them.
The Food and Drug Administration has approved a new drug for reducing the severity of chickenpox symptoms, the agency said.