• Biography

    Kayla Cristales is an associate in the Healthcare and Life Sciences Practice Group in the Dallas office of Haynes and Boone. Her practice focuses primarily on transactional and regulatory healthcare and FDA matters. While she advises clients on pure FDA matters and pure healthcare matters, her unique expertise in both areas makes her a valuable asset to the many clients whose businesses are subject to both FDA and healthcare laws, regulations, and rules, such as, for example, companies engaged in the manufacture, distribution, marketing, sale, promotion, or purchase of pharmaceuticals, biologics, or medical devices and the many ancillary activities in which such companies may be involved.

    On the healthcare side, Kayla routinely advises clients on a wide range of issues involving key regulatory areas, including the Stark Law; the Anti-Kickback Statute; state fraud and abuse laws; the Sunshine Act; state examining board rules; the Administrative Procedure Act; state corporate practice of medicine prohibitions, among a number of others. In doing so, she has added critical regulatory insight to a number of transactional operations and compliance reviews and helped healthcare clients address obstacles and navigate through the often overlapping state and federal healthcare laws.

    On the FDA side, Kayla has assisted with matters confronting a number of evolving FDA-regulated areas, including compliance with state and federal laws and regulations governing the marketing and/or distribution of products containing hemp-derived CBD (after the enactment of the 2018 Farm Bill). She also regularly counsels FDA-regulated clients in connection with labeling reviews; product classification analyses; manufacturing, development, commercialization, and/or supply agreement negotiation; and advertising, marketing, and other promotional communications, among many other areas.

  • Education and Clerkships

    • J.D., Southern Methodist University Dedman School of Law, summa cum laude; Order of the Coif; SMU Law Review
    • B.A., University of Oklahoma
  • Admissions

    • Texas