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The Office of Pharmaceutical Quality’s “One Quality Voice” is “well on its way to becoming a reality,” CDER Director Janet Woodcock said Tuesday. Read More
The FDA issued final guidance today formally adopting the U.S. Pharmacopeia’s strict naming rules for drug containing salt-based active ingredients. Read More
The FDA has granted orphan drug designation to Berkeley, Calif., drugmaker Xoma’s investigational treatment for congenital hyperinsulinism, a life-threatening disease that causes the body to produce excessive amounts of insulin. Read More
Israeli drugmaker Teva will pay $24 million to settle a pay-for-delay lawsuit over its generic version of AstraZeneca’s heartburn relief drug Nexium. Read More
The FDA has approved an sNDA for Novartis’ Promacta for the treatment of children six years and older with the chronic immune thrombocytopenia who have had a poor response to corticosteroids, immunoglobulins or spleen removal. Read More
An FDA associate commissioner and five associates are pushing for greater transparency around complete response letters issued to drugmakers when marketing applications are denied. Read More
A citizens advocacy group is accusing the FDA of wrongly expanding the indication of Vanda Pharmaceuticals’ sleep disorder drug Hetlioz by labeling it for use in sighted people. Read More