King & Spalding LLP

Partner

Nikki Reeves is an FDA and healthcare regulatory compliance lawyer with more than 25 years of experience. Nikki co-chairs the firm's Government Matters & Regulatory practice management group, which is comprised of 200+ lawyers and consultants in eight practice areas. Nikki previously co-chaired the firm’s Life Sciences and Healthcare Industry Group for six years, which is comprised of more than 450 lawyers across seventeen practice areas in the firm. In 2024, Nikki was a winner of Corporate Counsel's 2024 Women, Influence & Power in Law Award for Law Firm Thought Leadership.

As Deputy Chair of the FDA & Life Sciences practice, Ms. Reeves advises pharmaceutical and medical device companies on pre- and post-market FDA regulatory compliance and enforcement matters ranging from clinical trials, good manufacturing practices, to labeling, advertising, and promotion of FDA-regulated products. Nikki has been the lead FDA regulatory advisor to her clients on 250+ transactional matters. She conducts investigations into FDA clinical trials and post-marking noncompliance, acts as lead compliance and regulatory counsel for several companies under Corporate Integrity Agreements (CIAs) and has led several CMS Open Payments compliance audits. She is an expert on federal Open Payments, state, and international transparency/disclosure laws and leads two pharma and device industry compliance coalitions.