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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. Nikki was named a 2020 Law360 Compliance MVP, named a LMG Life Sciences Star in FDA Pharmaceutical and in FDA Medical Device from 2019-2023, and has been ranked nationally by Chambers USA since 2021 for Life Sciences: Regulatory Compliance and for Pharmaceuticals/Medical Products Regulatory.
As a partner in our FDA & Life Sciences practice, Nikki 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 200+ transactional matters. She 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 Sunshine, state, and international transparency/disclosure laws and leads two industry compliance coalitions.
Nikki counsels pharma and device companies on FDA inspections, Form 483s, Warning Letters, product recalls, import detentions, clinical holds, and other FDA compliance and enforcement matters. She conducts risk assessments and internal investigations into allegations of FDA and healthcare program noncompliance. She routinely advises company executives and board members and represents her clients before federal agencies. She has established robust compliance programs and policies for numerous life sciences companies. Nikki has also served as an interim General Counsel and as a Chief Compliance Officer for her life sciences clients.
Nikki leads two pharma and device industry coalitions on transparency and disclosure laws. The Ad Hoc Sunshine and State Law Compliance Group is a coalition she advises on federal Sunshine Act and state transparency/disclosure and gift ban laws. The International Marketing and Disclosure Compliance Group is a separate coalition of companies she advises on the growing area of transparency and disclosure laws and industry codes of conduct in the EU, Australia, Japan, and numerous other countries and regions.
King & Spalding’s FDA & Life Sciences Practice has been named Law360 Practice Group of the Year from 2017-2020. King & Spalding’s FDA & Life Sciences Practice is ranked by Chambers Legal, LMG Life Sciences, U.S. News, and Best Lawyers. According to Chambers USA, sources praise Nikki as being "thoughtful, quick to respond and available." -- Chambers USA (2022)
Nikki is a frequent speaker and author on FDA advertising/promotion, clinical trials, compliance, and transparency law matters. Nikki was also selected to Law360's 2021 Compliance Editorial Advisory Board and has served on the Advisory Board for FDAnews and the PCF Pharma Congress planning committee. She was formerly on the Food and Drug Law Institute (FDLI) Editorial Advisory Board for the FDLI Food & Drug Law Journal and a member of the FDLI Medical Device Committee. Nikki has also served on the Leadership Advisory Board for the National Women’s Law Center and on the Special Gifts Committee for the Arlington Free Clinic for more than ten years.
Nikki was elected by her partners in 2017 to serve for three years on the firm’s Policy Committee, which is the firm's executive management committee. Nikki served for many years on the firm’s Lateral Partner Committee and on the firm's Partners Committee, and was also the Hiring Partner for the Washington, D.C. office.
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