January 19, 2022

Volume XII, Number 19

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Paul T. Kim

Regarded as one of the top food and drug lawyers in Washington, Paul Kim draws on his extensive governmental experience to advise clients on legal, legislative and regulatory issues in food, drug and device law, Medicare and Medicaid coverage and reimbursement, and the conduct of clinical research. He represents leading biotechnology, pharmaceutical and medical device companies before the Food and Drug Administration (FDA), the Centers for Medicare and Medicaid Services (CMS), and Congress.

Paul uses his Capitol Hill experience in the enactment, amendment and implementation of the Food, Drug, and Cosmetic Act, and such landmark legislation as the Public Health Security and Bioterrorism Act, the Hatch-Waxman Amendments and the Orphan Drug Act to advise clients on compliance issues and regulatory approvals. He also assists with general FDA regulatory matters, collaborating with clients to develop comments, petitions, presentations and regulatory submissions for agency rulemakings, advisory committee proceedings, early collaboration and pre-submission meetings, and other meetings with key Federal decision-makers. Clinical research compliance, FDA product approval, CMS coverage and reimbursement issues, and bioresearch monitoring are additional areas of focus in Paul’s regulatory practice.

Paul also develops effective legislative and media strategies for industry clients, manages advocacy coalitions, and helps clients develop constructive relationships with key federal regulators and congressional decision-makers. He also represents clients before congressional committees and with in their dealings with individual members of the United States Senate and the House of Representatives, defends their interests in congressional oversight and investigations, and helps them prepare for hearings.

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Articles in the National Law Review database by Paul T. Kim

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