Print-Friendly PDF Print this page

Stephanie Philbin, a counsel in the firm’s FDA Group and a member of its Life Sciences Practice, concentrates on Food and Drug Administration laws. She joined Goodwin Procter in 2007.

Ms. Philbin advises clients on regulatory and compliance issues including those related to clinical trials, pre-market submissions, the Quality System Regulation, Medical Device Reporting, recalls, product importing and exporting, and product promotion. Ms. Philbin assists clients in responding to agency investigations and in filing comments with FDA to respond to various regulatory initiatives. She reviews SEC filings of FDA-regulated companies and conducts due diligence of companies as part of mergers and acquisitions and initial public offerings. Ms. Philbin also assists in litigation.

While in law school, Ms. Philbin served as the Articles Editor for the Georgetown Journal of Legal Ethics.

Prior to joining Goodwin Procter, Ms. Philbin was counsel at Wilmer Cutler Pickering Hale and Dorr. Ms. Philbin is a former instructor at Georgetown University Law Center’s Foundations for Foreign Lawyers.

Ms. Philbin is a member of the D.C. Bar Association. She is on the advisory board of BNA, Inc.’s Medical Devices Law & Industry Report.

Ms. Philbin frequently lectures on food and drug law. Most recently, in November 2013, she spoke on "Presenting Risk Information in Promotional Materials and Good Reprint Practices" at AdvaMed’s Advertising and Promotion of Medical Devices Program in Washington, D.C. Her other speaking engagements include:

  • “Post-Marketing Issues” for the Food and Drug Law Institute’s Introduction to Medical Device Law and Regulation (May 2014)
  • "Fundamentals of FDA Regulatory Device Law" and "Comprehending the 510(k) Clearance Process" at the American Conference Institute’s Second Annual FDA Boot Camp Devices Edition (October 2012)
  • "The Food and Drug Administration Safety and Innovation Act: The 2012 Device Amendments and Their Potential Effect" in a Bloomberg BNA webinar (October 2012)
  • "Off-Label Issues: Scientific Exchange and Unsolicited Requests" at the AdvaMed 2012 The MedTech Conference (October 2012)
  • "Premarket Approval Application" at the American Conference Institute's FDA Boot Camp Devices Edition (October 2011)
  • "Medical Devices: Classification and the Essentials of the Device Premarket Review Process" at the American Conference Institute’s FDA Boot Camp (March 2012 and March 2010)
  • "Changes to FDA’s 510(k) Program" in a BNA webinar (May 2011)
  • "Legal Considerations: Industry Use of Social Media" at MassMEDIC's program on Use of Social Media During Regulatory Uncertainty (May 2011)
  • "The FDA, the Internet & Social Media: Regulatory Issues and Evolving Policy" before the Medical Development Group (September 2010)
  • "Enforcement and Compliance" for the Food and Drug Law Institute’s Introduction to Medical Device Law and Regulation (March 2012 and March 2010)
  • "Post Marketing Issues" and "Quality System Regulation (QSR)" for the Food and Drug Law Institute’s Introduction to Medical Device Law and Regulation (January 2010)
  • "Presenting Risk Information in Promotional Materials" at AdvaMed’s Medical Technology Learning Institute’s program on Advertising & Promotion of Medical Devices in an Age of DTC and Social Media Marketing (November 2009)
  • "Post-Market Requirements and Concerns for Medical Devices" at the American Conference Institute’s FDA Boot Camp (July 2007)
  • "Device Postmarket Reporting in the Drug Safety Age" for AdvaMed (November 2006)
  •  "Preparing for and Responding to an FDA Inspection" for AdvaMed (May 2005)
  • "Medical Device Technologies and the FDA: GMPs for Combination Products" at the Virginia Biotechnology Summit (2004)

Ms. Philbin has co-authored numerous articles including "Emerging from the Laboratory: Regulatory Considerations" (The Journal of Biolaw & Business, 2004, co-authored with Mark A. Heller and Melisa Moonan), and "Part 11: The FDA’s New View" (Bio-IT World, April 15, 2003, co-authored with Mark A. Heller). She also contributed to "Legal Responsibility for RA Professionals: Mistakes Can Be Costly" by Mark A. Heller (Regulatory Affairs Focus, April 1998).

“Dealing with Adverse Events/Product Problems”
October 30, 2015
Silver Spring, MD

“Dealing with Adverse Events/Product Problems”
November 12, 2014
Silver Spring, MD

“Post-Marketing Issues”
May 7, 2014
Washington, D.C.

"Fundamentals of FDA Regulatory Device Law"
October 23, 2012
Chicago, IL

"Premarket Approval Application"
October 25, 2011
Chicago, IL

"Fundamentals of FDA Regulatory Device Law"
October 24, 2011
Chicago, IL

"Enforcement and Compliance"
March 9, 2010
Washington, D.C.