viernes, 15 de agosto de 2025

Lessons Learned From the Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) Program September 10, 2025 +++++

August 14, 2025 Workshop: Lessons Learned From the Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) Program Lessons Learned From the Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) Program September 10, 2025 https://www.fda.gov/drugs/news-events-human-drugs/lessons-learned-chemistry-manufacturing-and-controls-cmc-development-and-readiness-pilot-cdrp August 13, 2025 Workshop: Pediatric Developmental Safety Assessment: New Approach Methods Pediatric Developmental Safety Assessment: New Approach Methods December 5, 2025 https://www.fda.gov/drugs/news-events-human-drugs/pediatric-developmental-safety-assessment-new-approach-methods-12052025 August 12, 2025 Workshop: FDA/Center for Research on Complex Generics (CRCG) Workshop on Mastering Particle Size Analysis: A Step-By-Step Illustration of Techniques and Best Practices 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 Webinar: Eco-NAMs Webinar Series | State of the Science for Bioaccumulation: An Integrated, Weight of Evidence Approach Eco-NAMs Webinar Series | State of the Science for Bioaccumulation: An Integrated, Weight of Evidence Approach September 10, 2025 https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/eco-nams-webinar-series-state-science-bioaccumulation-integrated-weight-evidence-approach-09102025 Webinar: Navigating the Draft ICH M13B Additional Strengths Biowaiver Guideline ICH M13B Webinar: Navigating the Draft ICH M13B Additional Strengths Biowaiver Guideline September 11, 2025 https://www.fda.gov/drugs/news-events-human-drugs/ich-m13b-webinar-navigating-draft-ich-m13b-additional-strengths-biowaiver-guideline-09112025

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