Overview

Amy Judge-Prein provides regulatory and strategic counsel to companies involved in the development of pharmaceuticals, medical devices, and diagnostics. Amy recognizes the operational and financial considerations involved in creating and managing compliance and regulatory strategies, and works seamlessly with clients to achieve their research and product development goals.

Amy has been representing FDA-regulated clients for more than 22 years. She works with a range of clients, including large and small companies, pharmaceuticals, devices, biotech, diagnostics, and research institutions, providing advice on clinical research, FDA interactions, and FDA-regulated products.

In-House Counsel Experience

Before joining Faegre Baker Daniels, Amy practiced in house for 11 years, where she served as lead legal counsel for the development and marketing of portfolios of products, including negotiating label and advertising issues with global regulators and competitors. Amy’s in house responsibilities also included serving as lead legal counsel for many types of clinical trials, spanning thousands of patients, dozens of countries, and partnerships with government and academic institutions.

Faculty Positions

  • Indiana University Robert H. McKinney School of Law — Adjunct Faculty

Credentials

Bar Admissions

Indiana

Court Admissions

U.S. District Court for the Southern District of Indiana

Clerkships

U.S. District Court for the Southern District of Indiana, Hon. Sarah Evans Barker, 1994-1995

Education

University of Michigan Law School
J.D. cum laude (1992)

Denison University
B.A. magna cum laude (1989)

Insights & Events

Other Perspectives
  • Clarifying the Clinical Trial Process for Drugs and Biologics
    FDA Boot Camp, New York City, March 8, 2018
  • Clinical Research and IDEs
    Indiana Medical Device Manufacturers Council Regulatory Workshop, Indianapolis, May 17, 2017
  • Coming Soon to Research Near You! Major Changes in Human Research Rules!
    Co-presenter, Indianapolis, December 8, 2016
  • Introduction to FDA-Regulated Clinical Research
    Indianapolis Bar Association CLE, May 11, 2016
  • Clinical Trials/IDEs
    Indiana Medical Device Manufacturers Council, April 21, 2016
  • Drug Development
    ALS Association Educational and Scientific Symposium, Chicago, October 21,  2015
  • Clinical Trials and IDEs
    Indiana Medical Device Manufacturers Council Conference, Indianapolis, June 25, 2015
  • Biologics, Biosimilars and Beyond: Key Concepts, Regulatory Issues and Litigation Risks
    Moderator, ABA Biotech Regional Workshop, Cambridge, Massachusetts, June 12, 2014
  • Overview of Laws and Regulations Related to Billing/Reimbursement for Clinical Studies
    IMDMC Regulatory 101: Overview of Laws and Regulations Relating to Billing/Reimbursement for Clinical Studies Conference, Indianapolis, May 15, 2014
  • Could You Be Dealing With Regulated Research and Not Know It? Regulated Research, Ethics and FDA Basics: A Primer
  • Co-presenter with Jody DeFord of Eli Lilly and Company, Expert Insights on Fraud & Abuse, Government Investigations & Regulated Research in Health Care & Life Sciences, Indianapolis Bar Association CLE Update, February 20, 2014
  • Clinical Research Billing Compliance
    MAGI Clinical Research Conference — 2013 West, Las Vegas, October 27, 2013

Leadership & Community

Professional Associations

  • American Health Lawyers Association
  • Indiana Health Industry Forum — Clinical Trials Policy Task Force (Past Chair)
  • Faegre Baker Daniels Women's Forum for Achievement — Leadership Council, 2012-present

Civic Activities

  • Street Law Program — Working to educate local high school students with potential interest in a legal career about civil law topics
  • Denison University — Trustee
  • Indiana University Robert H. McKinney School of Law, Hall Center for Law & Health — Health Law Advisory Board (Co-Chair)
  • Summer Stock Stage — Past Board Member (Past Board President)
  • CICOA Foundation — Past Board Member
  • Julian Center — Past Board Member (Past Board Secretary)
  • United Way Campaign — Lilly Annual Campaign (Past Chair)

Honors

  • Indianapolis Business Journal — Women of Influence
  • Martindale-Hubbell — Peer Review Rating: AV® Preeminent™
  • Phi Beta Kappa
  • Mortar Board
  • Denison University — President's Medal
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