Drugs

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
M13A: Bioequivalence for Immediate-Release Solid Oral Dosage Forms – Implementing the Final Guidance

Number of lessons: 7
Putting the Pieces Together: REMS Logic Model in REMS Design, Implementation, and Evaluation

Number of lessons: 3