PROFILE

Ben Haas, Global Vice Chair of the Healthcare & Life Sciences Practice, advises clients across all stages of pre- and post-market US Food and Drug Administration (FDA) regulation and compliance.

Ben leverages extensive experience and a sophisticated understanding of FDA-regulated products to guide medical device, pharmaceutical, biotechnology, tobacco, food, cosmetic, and dietary supplement companies on:

• Pre-market product development, clinical, and pre-clinical testing
• FDA submissions
• Product promotion and labeling
• Compliance with good manufacturing practices
• Agency inspections and recalls
• Regulatory diligence for major public and private financings, mergers, and other transactions

Ben advises on corporate compliance, mergers and acquisitions, and other corporate transactions, and counsels on legislative and administrative rulemaking proceedings relating to healthcare government mandates.

Ben also counsels clients on compliance and regulatory matters arising under the Consumer Product Safety Act (CPSA) and other statutes administered by the US Consumer Product Safety Commission (CPSC). He also helps clients design and implement product recalls within the CPSC’s jurisdiction.

A recognized thought leader and member of the FDA bar, Ben regularly speaks on FDA regulatory and enforcement matters and has served on multiple committees for the Food and Drug Law Institute.