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All Courses

OTC Monograph Drug User Fee Program (OMUFA): Understanding FY 2025 User Fees and Registration

FDA CDER Overview: Certificates of Confidentiality

FDA Pre-Existing Tobacco Product (PTP) Determination Program

FDA CDER Bioresearch Monitoring: Electronic Submission Requirements for New Drug and Biologic Licensing Applications

FDA CFSAN Updated “Healthy” Nutrient Content Claim: Final Rule

FDA Generic Drugs Forum 2025

Model Master Files: Advancing Modeling and Simulation in Generic Drug Development and Regulatory Submissions

Navigating Controlled Correspondences to Support Generic Drug Development

Cell Therapies and Tissue-Based Products: A Public Workshop on Generating Scientific Evidence to Facilitate Development

BsUFA III Regulatory Science Pilot Program: Progress Update


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