Hundreds of FDA staff, industry professionals, lawyers, and others gathered in Washington, D.C. on May 17th and 18th to participate in the 2023 Food and Drug Law Institute (FDLI) Annual Conference. The agenda covered a broad range of current regulatory and legal issues facing the food, drug, medical device, biologics, and tobacco industries. Lachman Consultant Services […]
When a reference listed drug (RLD) product is discontinued from marketing, or if the RLD’s NDA application is officially withdrawn, we all know that the FDA must make a determination that the specific RLD was not discontinued from marketing or withdrawn for safety or efficacy reasons before it can approve an ANDA based on the […]
Two years after the FDA guidance on Control of Nitrosamines Impurities in Human Drugs and nearly a year after the publication of USP’s General Chapter <1469> Nitrosamine Impurities, where are we now and what have we learned? That was a question posed recently at the Association of Accessible Medicine’s GRx+Biosims 2022 conference. The session devoted […]
Today, the FDA advised that it “recently became aware of a nitrosamine impurity, Nitroso‑STG‑19 (known as NTTP), in certain samples of sitagliptin, a medicine used to treat type 2 diabetes mellitus. To avoid a shortage and help ensure patients have access to an adequate supply of the medicine, the FDA will not object to the temporary […]
Yesterday, the Agency expressed confidence that manufacturers of varenicline tablets containing the N‑nitroso-varenicline impurity can meet the FDA’s original acceptable intake limit of 37 ng or less per day. Their statement read: “FDA is now confident in manufacturers’ ability to supply patients with varenicline containing the N-nitroso-varenicline impurity at or below the agency’s acceptable intake limit […]
