Coleen W. Hill
Associate
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Phone: +1 215 979 1164
- Duane Morris LLP
30 South 17th Street
Philadelphia, PA 19103-4196
USA - Duane Morris LLP
1201 North Market St, Suite 501
Wilmington, DE 19801
USA
Coleen W. Hill is a trial attorney whose practice focuses on representing clients in the Life Sciences industry in complex commercial, regulatory, and products liability disputes. Ms. Hill has extensive experience litigating matters involving medical products regulated by the Food and Drug Administration (FDA) and the Federal Trade Commission, as well as issues arising under the Federal Food, Drug, and Cosmetic Act. Her experience includes, for example, representation of a defendant in one of the country’s largest multidistrict litigations involving a widely-used pharmaceutical product.
Ms. Hill also advises companies on regulatory compliance issues and assists with responding to regulatory actions, including FDA Form 483s and Warning Letters. She counsels pharmaceutical companies, biologics manufacturers, medical device companies, and cosmetic companies on complex issues arising under state and federal regulations.
Admitted to practice in both Pennsylvania and Delaware, Ms. Hill also litigates corporate governance disputes (including stockholder class and derivative litigation), statutory actions arising under Delaware corporate and alternative entity laws, and complex contractual disputes stemming from various corporate transactions.
Ms. Hill holds a leadership role in Duane Morris’s Life Sciences and Medical Technologies industry group and actively monitors, publishes, and presents on developing FDA issues affecting Life Sciences industry clients. She serves on a planning committee for the Food and Drug Law Institute and manages Duane Morris’s role as a member of the Editorial Board of the Food and Drug Law Journal.
Ms. Hill serves on the attorney Recruitment and Retention Committee for Duane Morris’s Philadelphia office. She is a 2016 cum laude graduate of Villanova University School of Law, where she was managing editor of production for the Villanova Law Review, and a summa cum laude graduate of Southern Illinois University.
Admissions
- Pennsylvania
- Delaware
- U.S. District Court for the Eastern District of Pennsylvania
- U.S. District Court for the District of Delaware
Education
- Villanova University Charles Widger School of Law, J.D., cum laude, 2016
- Managing Editor of Production, Villanova Law Review - Southern Illinois University, B.A., summa cum laude, 2013
Experience
- Duane Morris LLP
- Associate, 2020-present - Morris, Nichols, Arsht & Tunnell LLP
- Associate, 2016-2020
Professional Activities
- Editorial Review Board for the Food and Drug Law Journal Vol. 77, Issue 4, 2022
- Food and Drug Law Institute
- New to FDA Law and Regulation Planning Committee
Selected Publications
- Co-author, "FDA Issues Guidance on Remote Clinical Trial Activities," Duane Morris Alert, October 21, 2024
- Co-author, "FDA Issues Draft Guidance on Predetermined Change Control Plans for Medical Devices," Duane Morris Alert, September 23, 2024
- Co-author, "FDA Finalizes New Rule for Lab-Developed Tests," Duane Morris Alert, May 20, 2024
- Co-author, "FDA Warning Letters Explained: An Opportunity, Not a Threat," Duane Morris Alert, November 21, 2023
- Co-author, "FDA Issues Draft Guidance on Pre-market Submissions for Patient-Matched Guides to Orthopedic Implants," Duane Morris Alert, August 16, 2023
- Co-author, "Beauty and Personal Care Products Post-MoCRA Regulatory Compliance Checklist," Lexis Nexis Practical Guidance, June 2023
- Author, "Summary of the Director’s Update for FDA’s Center for Drug Evaluation and Research," FDLI News, May 18, 2023
- Co-author, "FDA Issues Draft Guidance on Predetermined Change Control Plans for Artificial Intelligence/Machine Learning-Enabled Device Software Functions," Duane Morris Alert, June 1, 2023
- Co-author, "FDA Issues Final Guidance on Clinical Decision Support Software," Duane Morris Alert, October 21, 2022
- Co-author, "FTC Publishes Proposed Changes to Guides Concerning the Use of Endorsements and Testimonials in Advertising," Duane Morris Alert, June 28, 2022
- Co-author, "FDA Issues Final Guidance on Initiation of Voluntary Recalls," Duane Morris Alert, March 16, 2022
- Co-author, "FDA Issues Draft Guidance on Content of Premarket Submissions for Device Software Functions," Duane Morris Alert, December 6, 2021
- Co-author, "FDA Issues Final Guidance on Form and Content of Unique Device Identifier Labeling System," Duane Morris Alert, July 26, 2021
- Co-author, "FDA Issues Final Guidance on Post-Approval Chemistry, Manufacturing and Controls Changes to Biologics," Duane Morris Alert, June 28, 2021
- Co-author, "Oklahoma to Begin Enforcing Challenged Patient Right-to-Choose Pharmacy Law," Duane Morris Alert, April 27, 2020
Selected Speaking Engagements
- Speaker, "When Things Go Wrong: Navigating Enforcement When the FDA, SEC, and DOJ Are All Involved," MassMEDIC Regulatory Roundup, November 15, 2023
- Moderator, “Business and Legal Trends Impacting Emerging Technologies: How to Protect IP in an Increasingly Challenging Legal Environment,” Duane Morris Life Sciences GC Bootcamp Series, May 23, 2023
- Speaker, "Recent Developments on the 'Fraud on the FDA' Theory of False Claim Liability," MassMedic Regulatory Roundup Event, Webinar, February 16, 2023
- Speaker, "When Innovation Outpaces Regulation," MassMEDIC Annual Conference, December 6, 2022