Kevin M. Madagan Photo
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Kevin is a health care and FDA regulatory attorney and member of the Reed Smith Life Sciences Health Industry Group. He advises primarily about health care and FDA issues related to the manufacturing, distribution, and sale of drugs (Rx, OTC, homeopathic), biologics, devices (Rx and OTC), combination products, and dietary supplements.

Credentials

  • University of Maryland School of Law, 2006, J.D., Health Law, Journal of Health Care Law & Policy - Manuscripts Editor (2005-2006), Staff Member (2004-2005);
    Maryland Association of Legislative Law Member; Maryland Student Health Law Association Member; Research Assistant in Health Law
  • Virginia Polytechnic Institute, 2000, B.S.

  • Maryland
  • District of Columbia

  • Drug Information Association (DIA)
  • American Bar Association
  • American Health Lawyers Association (AHLA)
  • Food & Drug Law Institute (FDLI)
    • Medical Devices Committee
  • Maryland Bar Association

Awards & Recognition

  • Ranked in Chambers USA for District of Columbia Healthcare: Pharmaceutical/Medical Products Regulatory, 2021-2023

Notable Quotes

  • 7 September 2021 “Compliance takeaways from FDA’s final ‘intended use’ rule” Compliance Week
  • 9 January 2018 "FDA guidance removes ambiguity, health experts say" Home Health Technology News
  • 5 December 2017 “FDA Approves First Drug With Digital Ingestion Tracking System” Digital Health Legal
  • 12 May 2016 "FDA Tackles 3-D Printing Considerations In Draft Guidance" The Gray Sheet
  • 31 August 2015 "Kim Kardashian corrects her Instagram drug ad," Wonkblog The Washington Post
  • 12 August 2015 "FDA Warns Drugmaker Over Reality Star's Social Media Promotion" iHealthBeat
  • July 2014 "FDA guidance clarifies position on correction of misinformation" eHealth Law & Policy
  • March 2014 "PROTECT health IT bill looks to reduce regulatory scope of FDA" eHealth Law & Policy

Civic and Charitable Activities

  • Deputy coordinator of the Pro Bono Committee of Reed Smith's Washington, D.C., office 
  • Member of the firmwide Pro Bono Committee
  • Lawyers Committee on Civil Rights