University of Arizona law professor Christopher Robertson calls for research on whether an off-label use of a medical product should be disclosed to p...
Federal Register notification of withdrawal: FDA withdraws approval of a Putney, Inc. ANDA for mupirocin ointment 2% because the product is no longer ...
Attorney Kurt Karst describes how the CDER Exclusivity Board reached its determination of the scope of three-year Morphabond exclusivity.
Two Johns Hopkins professors say that a European Medicines Agency decision to publish clinical study reports could undermine FDAs position that such r...
FDA accepts a Novartis supplemental NDA for expanded use of Zykadia (ceritinib) as a first-line treatment for patients with metastatic non-small cell ...
FDA approves an expanded indication for Celgenes Revlimid (lenalidomide) as maintenance therapy for patients with multiple myeloma following autologou...
FDA issues Dr. Reddys Laboratories a three-observation Form-483 after inspecting its Miryalaguda active pharmaceutical ingredients plant in Telangana,...
FDA clears Accelerated Diagnostics PhenoTest BC Kit for identifying bacteria and yeast that cause bloodstream infections.