Recognized as a global center for education, arts and culture, administration, and industry, Dublin Ireland was a beautiful and fitting backdrop for the MedTech Forum 2023, where Europe’s medical technology community congregated to collaborate on the future of the industry in a city well-known for its long history of shaping the future. MedTech Forum 2023 […]
The Food and Drug Law Institute (FDLI) recently held its 2023 Annual Conference on May 17-18 in Washington, D.C. where professionals from the food, drug, medical device, biologics, and tobacco industries gathered to hear important updates and panel discussions from a distinguished group of industry and FDA speakers. The Conference commenced with keynote addresses by […]
In the generic drug business, most times it is best to be first! This means trying to be first in development, submission, and (of course) approval. But, in order to have a chance of being first, you must know what to do, and that is especially true of knowing what the bioequivalence (BE) requirements are. […]
Join Lachman Consultants (Ireland) in Leipzig, Germany for the 2023 Parenteral Drug Association (PDA) Good Aseptic Manufacturing Conference on May 23 – 24, to discuss the implications of the new GMP Annex 1 and share insights to help you prepare. As a Gold Sponsor at this year’s event, Lachman will be represented by: John Darby, […]
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 […]
A Citizen Petition submitted recently by McDermott Will & Emory (here) on behalf of Vanda Pharmaceuticals requests that the FDA “revoke approval of Abbreviated New Drug Application (ANDA) No. 211654, submitted by MSN Pharmaceuticals Inc. (MSN), for 20 mg tasimelteon capsules, and order a recall of any product that has been distributed under ANDA No. 211654 (if any) […]
Yahoo News reported this morning (here) that the Supreme Court refused to wade into the waters of the skinny label case regarding the Teva V GSK case. We have written extensively about the skinny label issue (here, here, here, here, , here, here, here here, and here. That’s a lot of discussion, but this is […]
Based on the longstanding knowledge that diethylene glycol (DEG) and ethylene glycol (EG) are dangerous at levels that may exceed USP‑NF limits and because of the recent misadventures and deaths resulting from these incidents, the FDA has revised a 2007 guidance to provide further recommendations regarding the identification and quantification of these contaminants in drug […]
Coming off the March total of 117 (ninety‑six full approvals and twenty‑one tentative approvals), April’s numbers are good but fall short of any big records. April saw the OGD unofficially issue sixty‑four full‑approval actions and eleven tentative‑approval actions for a total of seventy‑five approval actions. If these figures hold firm when the official numbers are […]
The 2023 PDA Robotics and Automation Conference, which just concluded in Amsterdam, Netherlands, highlighted the significant new value and promise of advanced technologies, robotics, automation and digitization across the pharmaceutical value chain from clinical to manufacturing to distribution, and for all sectors including small and large molecule and medical device. Conference presentations and panels highlighted […]
