FDA/Center for Research on Complex Generics (CRCG) Workshop on Mastering Particle Size Analysis: A Step-By-Step Illustration of Techniques and Best Practices September 23 - 24, 2025

https://www.fda.gov/drugs/news-events-human-drugs/fdacenter-research-complex-generics-crcg-workshop-mastering-particle-size-analysis-step-step?utm_medium=email&utm_source=govdelivery FDA/Center for Research on Complex Generics (CRCG) Workshop on Mastering Particle Size Analysis: A Step-By-Step Illustration of Techniques and Best Practices Day 1: Tue, Sept. 23, 2025; 8:30 a.m. - 5:30 p.m. ET Day 2: Wed, Sept. 24, 2025; 8:30 a.m. - 4:20 p.m. ET This 2-day hybrid workshop addresses challenges in particle size characterization for complex generic drug products. It aims to enhance understanding of Dynamic Light Scattering (DLS) and Laser Diffraction (LD) techniques, tackle method development and validation issues, and provide hands-on experience with equipment. By bringing together industry experts, regulatory scientists, and instrument vendors, the workshop fosters collaboration to overcome hurdles in generic drug development, identify research needs, and improve regulatory guidance. Participants will gain valuable insights through theoretical presentations, practical demonstrations, and interactive discussions. https://www.complexgenerics.org/education-training/mastering-particle-size-analysis-a-step-by-step-illustration-of-techniques-and-best-practices/?utm_medium=email&utm_source=govdelivery