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