This course offers a comprehensive overview of the FDA regulatory landscape essential for professionals in the pharmaceutical industry and informative for others who have an interest in the development of drugs and biological products in the US. Participants will explore the full lifecycle of regulatory submissions, including IND applications and maintenance; safety reporting in clinical trials; NDA planning, content development, submission and FDA review. The curriculum covers special regulatory considerations for expedited development, development of product labeling, post-approval requirements, and standards for promotional activities.

Attendees will gain practical knowledge to plan and prepare IND and NDA submissions with insight into various regulatory approaches, pathways, and opportunities for FDA interactions. This will equip attendees with the tools to thoughtfully develop and communicate regulatory strategies throughout the product lifecycle, from early development through the post-marketing setting.

This basic to intermediate course employs a blend of real-world examples, interactive lectures, team workshops, an online pre-course module, downloadable resources, as well as a Hot Topics session that will discuss recent events. This foundational course focuses on prescription drugs and well-characterized biological products. The requirements specific to generic drugs, complex biologics, biosimilars, medical devices, and OTC monograph products are not covered in detail. However, the principles, as well as many of the regulations and processes, described in this course will also apply to these types of products.

Can't attend this live virtual offering? Register for the on demand version of this course.