Kayla J. Cristales

Kayla Cristales serves as counsel in Haynes Boone’s FDA Regulatory and Compliance Group. Her practice focuses on transactional and regulatory matters for FDA-regulated clients, particularly in the beauty/wellness and life sciences spaces. For example, Kayla regularly counsels cosmetic and OTC drug and device brand owners, retailers, and distributors in connection with packaging and label compliance and claim-related risk assessments; substantiation reviews; product classification analyses; manufacturing, development, commercialization, and/or supply agreement negotiation; and advertising, marketing, and other promotional communications, among many other areas involving the wide range of often complex and overlapping federal and state laws and regulations governing cosmetics, drugs (including biologics), and medical devices, respectively.

Kayla also has substantial experience in conducting diligence, negotiating key contractual terms, assisting with post-closing transitions, and other key elements of mergers and acquisitions involving FDA-regulated parties, as well as in advising issuers and underwriters on material regulatory matters and related considerations in connection with securities offerings and SEC filings in the life sciences space.

In addition, Kayla has significant experience with state and federal healthcare laws, which allows her to provide helpful guidance to life sciences companies that are subject to both FDA regulations, as well as applicable healthcare laws, such as the Anti-Kickback Statute, the Stark Law, the Sunshine Act, and analogous state laws (among others).