FDA Regulatory and Compliance

Haynes Boone attorneys serve as trusted advisors delivering timely, accurate and innovative counsel to FDA-regulated companies on a variety of transactional and regulatory matters. Our attorneys address complex regulatory and compliance challenges, risk management and multifaceted transactions for:

• Food manufacturers and processors;
• Restaurant chains, food retailers and other food distributors;
• Dietary supplement manufacturers and own label distributors;
• Medical device companies;
• Cosmetic and personal care product manufacturers and brands;
• Pharmaceutical and OTC drug companies;
• Biotechnology companies; and
• Diagnostic companies.

We assist FDA-regulated companies with all aspects of product development, labeling, advertising, pre-clearance or pre-approval issues, as well as post-market issues. Representative examples of our work include:

• Responses to FDA inspection observations, product detentions, warning letters, and other potential enforcement actions;
• Due diligence to support the acquisition of FDA-regulated product lines or companies and to support securities offerings;
• Develop regulatory and distribution strategies for novel products that will or may be FDA-regulated, including the analysis of the appropriate pathway for FDA clearance or approval;
• Provide risk management counseling, including self-evaluative audits, designing corrective action plans, and handling of possible past or existing regulatory violations;
• Provide regulatory analysis and crisis management during threatened or actual recalls;
• Strategic product development planning and labeling and claim review and substantiation, regulatory compliance, and risk management with respect to consumer and competitor actions;
• Support for the development of stronger GMPs and preventive controls;
• Review and advise on food preparation and handling and safety issues, including compliance with the Model Food Code and relevant local and state regulations and FDA regulations or guidance;
• Counseling on compliance with the Food Safety Modernization Act (FSMA);
• Provide effective advocacy and help to engage appropriate, specialized lobbyists and other consultants when needed.