This excerpt is from the management report titled “Managing Data and Documentation for FDA Inspections and Remote Assessments,” based on a webinar from FDAnews, A WCG Company. The presenter was…

This edition of Quick Notes features a CRL for Lykos Therapeutics NDA for midomafetamine for treating post-traumatic stress disorder and approvals for Amneal’s Crexont, Novartis’ Fabhalta and Citius Pharmaceuticals’ Lymphir.…

The FDA’s efforts to actively oversee the safety of medical devices after they’ve hit the market have begun to bear fruit, with the agency making strides toward setting up a…

The FTC has submitted a comment supporting the FDA draft guidance on interchangeable biosimilar drugs saying that the recommendations in the guidance would increase patient access to lower-cost prescription medications.…

In this edition of Quick Notes, we cover FDA nods for a new sterilization method for duodenoscopes, an updated device for sleep apnea, a smaller continuous glucose monitor and a…

The FDA has finalized advice for generic drug sponsors on seeking meetings with the agency to discuss the impact of a new or revised product-specific guidance (PSG) on their ANDA…

A cohort study recently published in JAMA Network Open has found that Eli Lilly’s blockbuster antidiabetic drug Zepbound (tirzepatide) is linked to lower risks of major complications compared to GLP-1…

The FDA has given marketing authorization for a novel device for at home syphilis testing using a single drop of blood. Source: Drug Industry Daily

During the second session of the 118th Congress, FDAnews will track important pending legislation, that has been acted on by Dec. 31, 2023, to keep you updated on laws and…

This edition of Quick Notes features approvals for Adaptimmune’s Tecelra, Purdue Pharma’s Zurnai, Servier Pharmaceuticals’ Voranigo and Aurobindo’s Estradiol. Source: Drug Industry Daily