Serra J. Schlanger Associate 202-737-4593
Serra J. Schlanger

Overview

Serra Schlanger advises clients on FDA regulatory strategy as well as compliance and enforcement issues. She assists clients with compliance with rules and regulations governing product advertising and promotion, corporate compliance matters, preparing regulatory submissions, and drafting regulatory policies and procedures. Ms. Schlanger counsels clients on federal and state health care fraud and abuse matters and defends clients in connection with government investigations, audits, qui tam actions, and other enforcement inquiries. She helps clients with contract matters and regulatory due diligence related to corporate transactional matters. Ms. Schlanger also advises clients on legal and regulatory issues associated with the privacy of health information (HIPAA), state licensure, and the Clinical Laboratory Improvement Amendments (CLIA).

Prior to joining the firm, Ms. Schlanger practiced in the health care and life sciences practice of a national law firm, where she provided regulatory and compliance counseling to a wide variety of health care providers, defended clients in government investigations, and advised clients on issues related to the Medicare and Medicaid programs.

Before beginning her legal career, Ms. Schlanger worked in clinical administration at Memorial Sloan-Kettering Cancer Center in New York City as a liaison between physicians, patients, researchers, and administrators.

Ms. Schlanger was a Leadership Scholar at the University of Maryland School of Law and graduated cum laude with a certification in Health Care Law. While attending law school, she was the Executive Editor of the Journal of Health Care Law & Policy and a member of the National Health Law Moot Court Team. As a law student, Ms. Schlanger interned at the U.S. Department of Health and Human Services, Office of the General Counsel, Public Health Division and the Office of the General Counsel at the University of Maryland Medical System.

Ms. Schlanger currently serves on the University of Maryland School of Law Alumni Board and as a Vassar College class officer.

Education

J.D., cum laude, University of Maryland Carey School of Law
B.A., Science, Technology, and Society, Vassar College

Admissions

District of Columbia
Maryland
American Bar Association
American Health Lawyers Association

Practice Areas
Industries
FDA Regulatory Categories