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The FDA has issued a request for information (RFI) for advancing model-informed drug development (MIDD) to assist CDER and CBER in identifying and prioritizing potential focus areas for future policy or guidance development. Read More
The FDA has updated its technical guide for sponsors of NDAs or BLAs on submitting clinical trial datasets to CDER’s bioresearch monitoring (BIMO) program. Read More
Following an FDA inspection of its North Carolina facility that found inadequate personnel training, non-implementation of quality control procedures and scuttle fly larva on employee clothing, Shanghai-based CARsgen Therapeutics has been issued a Warning Letter. Read More
Sponsors appear more informed and prepared than sites for the upcoming changes to the ICH E6 — Good Clinical Practices guideline, according to a newly published survey by Avoca, a WCG company. Read More
The CEO that founded Liveyon, a manufacturer and distributor of stem cell-derived products tied to bacterial infections requiring hospitalization, has plead guilty to felony distribution of unapproved drug products, the Department of Justice (DOJ) announced. Read More
In this edition of Quick Notes EU, we note a new EMA guidance on treating exposure to chemical agents used as weapons, the UK’s decision to offer Vertex’s gene editing therapy Casgevy via the NHS for treating an inherited blood disorder, approval of Regeneron’s Ordspono antibody for treatment of lymphoma, and of AstraZeneca’s Imfinzi and Lynparza for treatment of endometrial cancer. Read More
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