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.
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Tony Subketkaew, Suzie Trigg, Joanna Pearce and Neil Issar in Update Magazine: ‘FDA Guidance in Resp [...]
March 28, 2022

From the outset of the COVID-19 public health emergency, the U.S. Food and Drug Administration (FDA) engaged in policymaking at a blistering speed compared to its historically measured pace. Robert Califf, who previously led the agency under Obama, was recently confirmed as FDA commissioner, and Califf’s approach to agency guidance will be closely monitored by many stakeholders. With two COVID-19 [...]