We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
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
Regeneron Pharmaceuticals has confirmed that the FDA will not make a decision on approving its investigational multiple myeloma drug linvoseltamab for at least the next few months, citing problems encountered during the preapproval inspection of a contract manufacturer. Read More
Pfizer has announced its new digital platform — PfizerForAll — which will partner with a network of healthcare organizations to help patients find and access care, fill prescriptions and find potential savings on Pfizer medicines. Read More
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 regulations that could impact your business. Read More
This edition of Quick Notes features announcements of Baxter’s agreement to sell its Vantive Kidney care segment, Merck’s B-Cell depletion therapy acquisition, Triastek collaboration with BioNTech and Crown Laboratories and Revance Merger. 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
This week, the FDA published final guidance on product-specific guidance meetings between FDA and ANDA applicants and an electronic submission template for medical device de novo requests. Draft guidance was published on change control plans for medical devices and product-specific guidances. 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
In this edition of Quick Notes, we look at positive news on development of drugs and treatments for multiple myeloma, RSV and follicular lymphoma as well as the discontinuation of an unsuccessful trial in treating extensive-stage small cell lung cancer. 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 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 David Chesney, a former director of the FDA’s San Francisco District Office who is now principal and general manager of DL Chesney Consulting. 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