In an ever-increasing effort, the Office of Generic Drugs (OGD) is keeping on top of this aspect of industry’s desire to obtain guidance on establishing bioequivalence for generic drug products. Today FDA published new bioequivalence (BE) guidance for 35 drug products and revised guidance for 8 previously issued recommendations. The entire listing of the newly […]
In a recent speech given to the 2016 Opioid and Drug Abuse Summit, FDA Commissioner Dr. Robert Califf outlined the FDA’s plans on addressing the opioid abuse epidemic and touched on a number of important and critical issues that underscore the tough job ahead of them. He emphasized that there needs to be a multipronged […]
Just when you thought it was safe to go back into the ocean, someone spots another shark. As noted in our post yesterday (here), the Office of Generic Drugs (OGD) fully approved 63 ANDAs and tentatively approved 16 ANDAs in March. We were hoping to see approval actions outpace receipts, however, much to our surprise, […]
FDA had the second highest monthly post-GDUFA number of full ANDA approvals at 63, and with 16 tentative approvals the total for approval actions for March 2016 hits 79. The full ANDA approval picture is looking a bit rosier with the second highest month this FY and also the second highest number of full approvals […]
The FDA has published a proposed rule regarding Time and Extent Applications (TEAs) that will establish timelines and metrics associated with their review. Just to remind you, a TEA is now the preferred option to add a product to an over-the-counter (OTC) monograph for products that were initially marketed in the United States after the […]
