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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 Draft guidance was published on change control plans for medical devices and product-specific guidances.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
The FTC has submitted a comment supporting the FDA draft guidance on interchangeable biosimilar drugs saying that the recommendations in the guidance would increase patient access to lower-cost prescription medications.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
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 receptor agonist (RA) drugs, suggesting additional clinical boons for the highly sought medication. 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 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