November 17, 2018

Neil P. Di Spirito

NEIL P. DI SPIRITO* is a Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, and the St. Petersburg offices of Epstein Becker Green. He has more than two decades of experience helping pharmaceutical, medical device, biologic, and life sciences clients comply with U.S. and international drug, biologic, and medical product regulation.

Mr. Di Spirito:

  • Provides regulatory and enforcement counsel to companies of all sizes on products regulated by the U.S. Food and Drug Administration (FDA)

  • Advises clients on preparing new drug, biologic license, pre-market approval, and 510(k) applications

  • Counsels clients on legal issues relating to the design and implementation of clinical trials

  • Negotiates manufacturing, supply, and quality assurance agreements

  • Conducts FDA regulatory reviews of product labeling and promotional materials

  • Conducts FDA regulatory due diligence assessments as part of mergers, acquisitions, and other business transactions

  • Assists clients in the negotiation and drafting of FDA regulatory provisions for business contracts

  • Advises clients regarding FDA compliance audits, and conducts internal investigations on behalf of clients

  • Handles licensing, labeling issues, managed care issues, FDA enforcement defense and State of Florida enforcement matters, civil seizure claims, consent decrees, Medicare and Medicaid issues, and federal supply issues

In addition, Mr. Di Spirito has successfully litigated against the FDA, defending clients on alleged cGMP violations and approval issues. He also has substantial experience negotiating with the FDA’s Office of Chief Counsel and with the Regulatory, Compliance, and Review departments within the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, and the Center for Devices and Radiological Health on matters of policy and product approvals. 

Articles in the National Law Review database by Neil P. Di Spirito

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