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    Global Problem Solving from Covington: Deal with Complex Problems Anywhere in the World

Thomas J. Cosgrove

Partner

Washington +1 202 662 5260

  • About
  • Credentials
  • About

    Tom Cosgrove is a partner in Covington’s Food, Drug and Device Practice Group. He joined Covington in 2017 from the Food and Drug Administration (FDA), where he was a senior official charged with ensuring the quality of drugs and therapeutic biologics marketed to U.S. patients. Tom brings a wealth of experience to bear in helping clients navigate the complex world of pharmaceutical compliance and enforcement in the United States and around the globe.

    At FDA, Tom held senior leadership positions within the Office of Compliance in the Center for Drug Evaluation and Research (CDER), including leading the organization as Acting Director in 2016. Beginning in 2014, he led the Office of Manufacturing Quality (OMQ), where he was responsible for CDER’s enforcement activities covering current good manufacturing practice (CGMP) and drug quality. In this role, Tom was responsible for setting FDA’s CGMP enforcement priorities and for clearing warning letters, import alerts, and referrals for civil and criminal enforcement. He also played a central role in the FDA's deliberations concerning the approval of marketing applications submitted by companies with manufacturing compliance challenges.

    As Acting Director of CDER Compliance in 2016, Tom oversaw OMQ as well as the offices responsible for enforcing FDA’s requirements for drug approval and labeling, human drug compounding, drug supply chain security and integrity, and clinical trials and bioequivalence studies.

    He is a frequent speaker at conferences and trainings focused on drug quality, compliance, and enforcement at home and abroad.

    Areas of Expertise

  • Practices and Industries
  • Credentials
    Education
    • University of Michigan Law School, J.D., 2000
        • magna cum laude
        • Order of the Coif
        • Michigan Law Review, Contributing Editor
    • New York University, M.A., 1997
        • magna cum laude
    • Clark University, B.A., 1994
        • magna cum laude
        • Phi Beta Kappa
    Bar Admissions
    • District of Columbia
    • Maryland
    Government Experience
    • U.S. Department of Health and Human Services – Food and Drug Administration
    Judicial Clerkship
    • Hon. Catherine C. Blake, U.S. District Court, District of Maryland, 2001 - 2002
    Previous Experience

    U.S. Food and Drug Administration

    • Acting Director, Office of Compliance, Center for Drug Evaluation and Research (CDER) (2016-2017)
    • Director, Office of Manufacturing Quality, CDER (2014-2017)
    • Director, Office of Unapproved Drugs and Labeling Compliance, CDER (2013-2014)
    • Associate Chief Counsel for Enforcement (2010-2013)

    Areas of Expertise

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