From Rookie to Ready: Handling Your First FDA-Regulated Case

Handling your first healthcare law case involving FDA regulation can be daunting, but this course will provide the key insights and strategies you need to succeed. In this CLE, we will walk through the essentials of FDA law, including regulatory frameworks, enforcement risks, and best practices for client representation. Presented in a podcast-style discussion, this session will cover practical approaches to issue-spotting, compliance challenges, and advocacy strategies in FDA-regulated matters. Whether you are a new attorney or transitioning into healthcare law, this course will give you the foundation to confidently handle your first case.

Learning Objectives:

1. Identify key statutes, regulations, and agencies involved in healthcare law and FDA oversight
2. Break down compliance risks, enforcement actions, and potential liabilities affecting clients
3. Develop and identify best practices for advising clients, responding to FDA inquiries, and handling regulatory disputes
4. Navigate warning letters, consent decrees, and litigation strategies related to FDA compliance