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

Overview

Serra Schlanger advises clients on FDA regulatory strategy as well as compliance and enforcement issues. Her practice focuses on the intersection of FDA and healthcare laws. She assists clients with compliance with the rules and regulations governing product advertising and promotion, interactions with healthcare providers, telemedicine and telehealth, state drug price transparency efforts, the Sunshine Act and state marketing restrictions and reporting requirements. 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 corporate compliance and contract matters, drafting regulatory policies and procedures, 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 is a member of the Center for Telehealth & eHealth Law (CTeL) Legal Resource Team, and currently serves on the Food & Drug Law Institute’s (FDLI) Webinar Programs Committee and as a Vassar College class officer. She sings with the Congressional Chorus in Washington, D.C. and is a former member of the University of Maryland School of Law Alumni Board.

Education & Admissions

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

Honors & Awards

LMG Life Sciences, Shortlist for 2019 US Rising Star – Regulatory

Speaking Engagements

  • InformaConnect Drug Pricing Transparency Congress, Panelist: Ask the Experts – What Keeps You Up at Night?, November 9-10 and 16-17, 2021
  • Samford University Cumberland School of Law, Developments and Trends in Health Care Law 2021, Panelist: Federal Issues and COVID, October 1, 2021
  • International Bar Association Healthcare and Life Sciences Law Committee, FDA Regulation of Digital Health, July 22, 2021
  • CTel Digital Health Summit, Get to Know FDA’s Digital Health Center of Excellence, June 9-11, 2021
  • Vector Health, Panelist:  Global Monitoring and Analytics, April 20,2021
  • FDLI Introduction to Medical Device Law and Regulation, Registration and Listing, March 2, 2021
  • George Mason University Scalia Law School Law & Economics Center, Emerging Issues in the Economics and Law of Pharmaceutical Regulation micro-symposium, Panelist: Federal Efforts to Control Pharmaceutical Prices: Executive Orders and Congressional Action, January 28, 2021
  • CTeL Digital Health Summit, Telehealth Devices and FDA’s Emergency Use Authorization: Liability and Post-Pandemic Use, December 2, 2020
  • InformaConnect Drug Pricing Transparency Congress, Analyze Price Disclosure Requirements to Health Care Providers (HCPs), Panelist: Ask the Experts – What Keeps You Up at Night?, November 16-17, 2020
  • FDLI Advertising and Promotion for Medical Products Conference, Panelist: Rise of Docfluencers/Nursefluencers – Are “Docfluencers” the new KOL?, October 28-30, 2020
  • CTel Digital Health Summit, Is This a Medical Device? FDA Regulation of Digital Health and Telemedicine,  June 17, 2020
  • FDLI/FDA CDRH Training Course, Enforcement and Compliance, November 1, 2019
  • FDLI/CDC Training Course, Laboratory Developed Tests, April 23, 2019
  • FDLI New to Food and Drug Law Group, Telemedicine: Key Issues to Consider When Advising Clients, March 7, 2019
  • FDLI/FDA CDRH Training Course, Enforcement and Compliance, June 2018
  • Health Care Compliance Association (HCCA) 20th Annual Compliance Institute, Top Five Hospice Risk Areas: What you Need to Know and Do Now, April 18, 2016
  • National Association for Home Care & Hospice (NAHC) Annual Meeting & Exposition, How to Mitigate Risk: Enforcement Trends in Home Health and Hospice, October 20, 2015
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