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Pharmaceutical and biotechnology product development; product approvals involving New Drug Applications and Biologics License Applications; compliance standards for product promotion and marketing and post-approval requirements, including compliance with Good Manufacturing Practices and safety reporting; and conducts regulatory due diligence in corporate transactions.
1983-present, Partner, Hogan Lovells; 1981-83, Executive Assistant to the Commissioner of the FDA; 1975-81, FDA's Office of Chief Counsel - Associate Chief Counsel for Biologics, Associate Chief Counsel for Foods, and Associate Chief Counsel for Enforcement.
The George Washington University Law School (JD, with honors, 1972); University of Rochester (BA, 1969).