Drugs

OTC Monograph Drug User Fee Program (OMUFA): Understanding FY 2025 User Fees and Registration
Number of lessons: 4
FDA CDER Overview: Certificates of Confidentiality
Number of lessons: 3
FDA CDER Bioresearch Monitoring: Electronic Submission Requirements for New Drug and Biologic Licensing Applications
Number of lessons: 3
FDA Generic Drugs Forum 2025
Number of lessons: 40
Model Master Files: Advancing Modeling and Simulation in Generic Drug Development and Regulatory Submissions
Number of lessons: 4
Navigating Controlled Correspondences to Support Generic Drug Development
Number of lessons: 10
BsUFA III Regulatory Science Pilot Program: Progress Update
Number of lessons: 7
FDA Clinical Investigator Training Course (CITC) 2024
Number of lessons: 26
FDA Regulatory Education for Industry (REdI) 2024 Conference – Plenary and Drugs Track
Number of lessons: 16