About Tina Hu-Rodgers

Tina is Co-Leader of the firm’s Life Sciences Industry Team, and a shareholder in the FDA/Biotechnology group. She focuses her practice on issues related to the approval, regulation, promotion, sale and reimbursement of drugs, medical devices, biologics, dietary supplements, foods and cannabis-related products.

In addition to advising clients on how to obtain approvals for their FDA-regulated products, Tina’s experience includes reviewing and revising the labeling of drugs, medical devices, foods and dietary supplements to ensure compliance with the FDA law and regulations. She works with clients to petition the FDA to ensure the safety and effectiveness of drug products on the market, and assists clients in a wide range of compliance and enforcement matters. She also advises clients on user fee issues, federal and state Sunshine Act reporting obligations, state price transparency disclosure rules, and state licensing requirements.

Tina is a thought leader on artificial intelligence and machine learning in the life sciences industry. She has spoken frequently and published several articles on AI/ML in drug discovery and development as well as FDA’s regulation of AI/ML-powered medical devices.