Marie Dorat

June 2025, the FDA finalized guidance on Post-Warning Letter Meetings under GDUFA III, following its September 2023 draft. The guidance, titled “Post-Warning Letter Meetings(PWLM) Under GDUFA,” outlines the process for requesting and conducting meetings to address current good manufacturing practice (CGMP) deficiencies cited in FDA warning letters. Although, primarily aimed at generic drug manufacturers, the guidance offers valuable insights for all FDA-regulated industries, including...

Introduction Brazil’s National Health Surveillance Agency (ANVISA) oversees the registration of medical devices, ensuring they meet safety, efficacy, and quality standards before entering the countries market. Manufacturers of FDA-compliant devices (those already cleared or approved by the U.S. Food and Drug Administration), Brazil offers pathways that can leverage U.S. approvals to streamline the process. This is particularly relevant for devices classified under FDA Classes I, II, and III,...

You're an auditor diving into the high-stakes realm of FDA i and ISO 13485 audits, where one undocumented deviation could spell doom for a medical device or pharmaceutical empire. Let this article serve as your witty roadmap. While these tidbits don't scream "FDA" or "ISO 13485" from the rooftops, (they can be used for any type of audit) their gems you can use for navigating the human side of audits.  Understanding auditees, nailing interviews, mastering listening, spotting fraud, and these...