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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