Drugs

FDA Draft ICH M13B Additional Strengths Biowaiver Guideline Webinar

Number of lessons: 2
FDA Compounding Quality Center of Excellence Annual Conference 2025

Number of lessons: 25
FDA Cell and Gene Therapy Roundtable (June 2025)

Number of lessons: 1
FDA Generic Drug Science and Research Initiatives Public Workshop 2025

Number of lessons: 13
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