概览
Fundamentals of IND/NDA submissions and Postmarketing Regulatory Requirements
Learn about FDA regulations and expectations for the content, submission, and review of INDs/NDAs and the importance of regulatory strategy. This comprehensive course employs a blend of lectures, workshops and online precourse modules. The course focuses on prescription drugs and well characterized biological products and not the regulatory process for devices, generic products, OTC products or traditional biologics.
Course Level: Beginner