Drugs

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
Global IDMP Implementation – Getting Closer to the Goal

Number of lessons: 5
ICH M12 Drug-Drug Interaction Studies Final Guidance

Number of lessons: 6
Advancing Generic Drug Development: Translating Science to Approval 2024

Number of lessons: 18
Electronic Drug Registration and Listing (eDRLS) Using CDER Direct

Number of lessons: 10