Scott Kaplan

Scott Kaplan

Senior Associate
Washington, D.C.

Email scott.kaplan@​hoganlovells.com

Phone +1 202 637 5465

Fax +1 202 637 5910

Practice groupGlobal Regulatory

Scott Kaplan helps pharmaceutical and biotechnology clients achieve and maintain compliance with complex Food and Drug Administration (FDA) requirements.

Drawing on his deep understanding of the FDA's civil and criminal enforcement, Scott prepares clients for FDA inspections and works with them to respond to FDA 483s, Warning Letters, import alerts, investigations by the Office of Criminal Investigations, and other FDA enforcement actions.

Scott provides experienced counsel on Current Good Manufacturing Practice regulations, data integrity issues, product labeling, and Drug Supply Chain Security Act implementation, among others.

Before joining Hogan Lovells, Scott served as Associate Chief Counsel for Enforcement in the FDA's Office of the Chief Counsel. At the FDA, Scott helped the agency resolve seizures, injunctions, administrative detentions, and criminal prosecutions, in addition to serving as a Special Assistant U.S. Attorney. Scott also acted as counsel for compliance matters to the FDA's district offices. Prior to his tenure at the FDA, Scott clerked for the Hon. Helene N. White of the U.S. Court of Appeals for the Sixth Circuit.

Education and admissions

Education

J.D., University of Pennsylvania Law School, magna cum laude, Order of the Coif, 2009

M. Bioethics, University of Pennsylvania Center for Bioethics, 2009

B.A., University of Pennsylvania, cum laude, 2002

Bar admissions and qualifications

District of Columbia

Pennsylvania

Latest thinking and events

Sponsorships and Speaking Engagements

ACI's FDA Boot Camp (New York)

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