Overview
Amy Judge-Prein leads the firm's FDA-regulated products practice. She 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 24 years. She works with a range of clients, including large and small companies, pharmaceuticals, HCT/Ps, devices, biotech, diagnostics, and research institutions, providing advice on clinical research, FDA interactions, and FDA-regulated products.
In-House Counsel Experience
Before joining Faegre Drinker, 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.
Services & Industries
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)
Experience
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2019 1 min readHealth System Navigates Human Research WorkHealth & Life Sciences Clinical Research Hospitals & Health Systems Government & Regulatory Affairs FDA-Regulated Products
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2019 1 min readMedical Device Manufacturer Performs Global Clinical TrialsMedical Devices & Products Health & Life Sciences Government & Regulatory Affairs FDA-Regulated Products Public Companies & Governance
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2019 1 min readPharmaceutical Company Updates Global Website and Clinical Pipeline PagePharmaceuticals & Biologics Health & Life Sciences Government & Regulatory Affairs
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2019 1 min readVenture Capital Investment Team Completes Regulatory Due Diligence for Investment in Company with FDA-Regulated ProductsHealth & Life Sciences Government & Regulatory Affairs FDA-Regulated Products Corporate Venture Capital
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2019 1 min readMedical Diagnostic Company Navigates Promotional Issues with Product MarketingMedical Devices & Products Health & Life Sciences Corporate
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December 2018 1 min readEndocyte Acquired by Novartis in $2.1B AgreementPharmaceuticals & Biologics Health & Life Sciences Corporate Antitrust Mergers & Acquisitions
Insights & Events
Latest
Insights
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
- Indiana Health Industry Forum — Clinical Trials Policy Task Force, Past Member (Past Chair)
- Faegre Baker Daniels Women's Forum for Achievement — Leadership Council, 2012-present
- Indianapolis Bar Foundation — Fellow, 2018
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 — Board of Trustees, 2013-19
- Indiana University Robert H. McKinney School of Law, Hall Center for Law & Health — Health Law Advisory Board, Board Member (Past Co-Chair)
- Summer Stock Stage — Past Board Member (Past Board President)
- CICOA Foundation — Past Board Member
- JDRF, Indiana Chapter Board of Directors, 2016-19
- Julian Center — Past Board Member (Past Board Secretary)
- Women's Fund of Central Indiana OPTIONS Class of 2002
Honors
- Indianapolis Business Journal — Women of Influence
- Faegre Baker Daniels — Pro Bono Honor Roll, 2018
- Martindale-Hubbell — Peer Review Rating: AV® Preeminent™
- Phi Beta Kappa
- Mortar Board
- Denison University — President's Medal
- Indianapolis Bar Foundation — Distinguished Fellow