This excerpt is from the management report titled “Using Real-World Evidence in Drug and Device Submissions,” based on a webinar from FDAnews, A WCG Company. The presenters were Kristin Zielinski Duggan and Sally Gu of the Washington, D.C., law firm Hogan Lovells. Read More

Failure to conduct complete testing on sterile injectables, falsified monitoring records of areas used for aseptic filling lines as well as falsified cleaning records are among the serious lapses documented in the FDA’s Aug. 15 Warning Letter to Eugia Pharma Specialties of Hyderabad, Telangana, India. Read More

Citing ethical and data concerns, four US lawmakers have begun an investigation into clinical research conducted jointly by American biopharma firms and the Chinese military, as well as trials run in China’s Xinjiang region, where the US claims a genocide is being carried out against the area’s Uyghur population. Read More

In this edition of Quick Notes EU, we note a revised EMA guideline on pharmacovigilance, a call by EMA to revoke authorization of Ocaliva for treatment of primary biliary cholangitis — an autoimmune disease that destroys the liver’s bile ducts, a European Commission survey on electronic instructions for use for medical devices, a new pilot program for developers of orphan medical devices, and a thumbs down in the UK for Enhertu for treatment of HER2-low breast cancer by the National Health Service. Read More

Drastic changes in drug development mean quality management approaches are more critical than ever, with meaningful advancement hinging on cultural shifts, cross functional alignment and top-down approaches within organizations, as well as thoughtful, stakeholder-informed trial designs. Read More

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. Read More

The FTC has submitted a comment supporting the FDA draft guidance on interchangeable biosimilar drugs saying that the recommendations in the guidance would increase patient access to lower-cost prescription medications.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

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 development programs. Read More

This edition of Quick Notes features approvals for Adaptimmune’s Tecelra, Purdue Pharma’s Zurnai, Servier Pharmaceuticals’ Voranigo and Aurobindo’s Estradiol. Read More

Velocity Pharma’s lack of oversight of the quality of the eye drops its contract manufacturer — Kilitch Healthcare India Limited who received its own Warning Letter for the eye drops — has earned it an FDA Warning Letter. Read More

Omega Tech Labs received an FDA Warning Letter for inadequate procedures to prevent microorganisms in its combination product and failure to meet water quality standards in manufacturing following a Jan. 17-22 inspection. Read More

Novartis’ 2022 complaint against several generic drugmakers for allegedly infringing on a patent for its blockbuster heart failure drug Entresto (sacubitril/valsartan) was denied on Tuesday, but the judge gave the company a stay in the order to allow it to appeal in federal court. Read More