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Nikki Reeves is an FDA and healthcare regulatory compliance lawyer with more than 20 years of experience. Nikki co-chairs the firm’s Life Sciences and Healthcare Industry Group, which is comprised of more than 400 lawyers across seventeen practice areas in the firm. Nikki was named a 2020 Law360 Compliance MVP, named a 2019, 2020, and 2021 LMG Life Sciences Star in FDA Pharmaceutical and in FDA Medical Device, and is ranked by Chambers USA for Pharmaceuticals/Medical Products Regulatory. 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 to 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). 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.
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 serves on the Advisory Board for FDAnews. 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.
Nikki was elected by her partners in 2017 to serve a three-year term on the firm’s Policy Committee, which is the executive management committee. Nikki served for three years on the firm’s Lateral Partner Committee and on the firm's Partners Committee. She was also the Hiring Partner for the Washington, D.C. office.
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