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All Lessons

Download Presentation Slides & Transcript (Model Master Files: Advancing Modeling and Simulation)

Download Presentation Slides and Transcript (Statistical Risk)

Download Slides & Transcript (Compounding)

Download Slides & Transcript (ICH M12 Drug-Drug Interaction Studies)

Download Slides & Transcript (IDMP)

Download Slides & Transcript (OMUFA)

Download Slides & Transcript (OTGP)

Download Slides & Transcript (REMS)

Download Slides & Transcript (Rx Promos)

Download Transcripts (FDA Compounding Conference 2025)

Download Webinar Transcript (Bioresearch Monitoring: Electronic Submission Requirements)

Download Webinar Transcript (Certificates of Confidentiality)

Download Webinar Transcript (OMUFA: Understanding FY 2025 User Fees)

Download Workshop Agenda: FDA Generic Drug Science and Research Initiatives Public Workshop 2025

Drug Enforcement Administration (DEA) Quota Essentials for Outsourcing Facilities

Drug Shortage Mitigation by Outsourcing Facilities

Dynamic Light Scattering Theory, Practice, and Regulatory Perspectives (Particle Size Analysis)

Eco-NAMs Webinar Series: State of the Science for Bioaccumulation: An Integrated, Weight of Evidence Approach

Electronic Submission Gateway (ESG) Modernization: ESG NextGen 

End-to-End Production of a Drug in Shortage by Outsourcing Facilities

Enhancing Clinical Trial Innovation (REdI 2024 – Drugs Track)

Environmental Monitoring in Compounding

Establishing Standardized Formulations (FDA Compounding Conference 2025)

Experiences from Post-Complete Response Letter (CRL) Scientific Meetings in GDUFA III

Exploring Bioequivalence Considerations for Controlled Correspondences: Assessment and Best Practices

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