With more than 20 years of experience focused on Food and Drug Administration (FDA) regulated products, Colleen Heisey has a strong understanding of the legal, regulatory, and compliance issues facing drug, biologics, medical device/diagnostic, and food/dietary supplement clients. Her practice involves strategic counsel to clients navigating near-market and post-market opportunities and obligations, including matters related to product jurisdiction, pathways to market, regulatory exclusivities, accelerated approvals, orphan drug status, adverse event reporting, recalls, and managing federal agency inquiries and enforcement actions.
A business-oriented problem solver, Colleen evaluates and advises on product advertising and promotion and has helped life sciences companies launch dozens of prescription and over-the-counter (OTC) drug and device products. She has worked with regulated industries to develop and implement right-sized comprehensive compliance programs. Colleen's distinct skills and experiences are deployed to serve clients as they perform due diligence on products and targets and negotiate license, collaboration, acquisition, and other commercial agreements. She also supports robust teams in contract disputes and arbitration arising from commercial agreements involving regulated products and in litigation arising under the Federal Food, Drug, and Cosmetic Act (FDCA).
Colleen maintains an active presence in the Food and Drug Law Institute, speaking and writing for the organization, as well as serving on planning and products committees. As a first-generation college graduate, she is a proud member of the Board of Trustees of Lycoming College.
经验
其他出版物
- May 2022
Are Your Labels Up to Date? Ensuring Compliance With the USDA’s National Bioengineered Food Disclosure Standard
- June 5, 2024
Personal Care Branding: Advertising Issues, Challenges and Litigation Trends - 2024 and Beyond (PCPC, Legal & Regulatory Conference) - November 2023
All Roads Lead to Compliance: Enforcement Trends from Agencies and Consumer Protection Organizations (FDLI, Advertising & Promotion for Medical Products Conference) - October 14, 2022
Recent Trends in Enforcement and Practical Examples to Ensure Compliance (FDLI, Advertising and Promotion for Medical Products Conference) - March 16, 2022
FDLI Careers Over Coffee March: Hiring Process Tips & Tricks (FDLI) - October 13, 2021
Closed Doors Lead to Open Windows: Emerging Trends in Virtual Sales Force Tools (FDLI, Advertising and Promotion for Medical Products Conference) - September 29, 2021
Exploring FDA’s Expedited Programs: Applicability and Eligibility (ACI’s 37th FDA Boot Camp: American Conference Institute) - February 4, 2021
Fundamentals of Vaccine Regulation: Pathways to Market (FDLI) - October 28, 2020
Practical Considerations for Successful Remote-Based Marketing and Compliance Strategies - Health Care Provider Access and Sales Training (FDLI, Advertising and Promotion for Medical Products Conference) - August 20, 2020
How to Introduce Clients to the FDA-Regulated Space: A Sharing Session (FDLI, Law Over Lunch) - April 24, 2020
Face Masks and Their Use in the Workplace (Original Equipment Suppliers Association) - January 2019
Blockchain in Healthcare, New York State Bar Association Annual Meeting - December 4, 2018
Drug Quality and Security Act, Title I – Inspections and Enforcement in the Compounding World (FDLI) - October 10, 2018
Regulation of Medical Products in the EU and Combination Products (Drug Information Association) - May 4, 2016
Compliance in the Precision Medicine Era: Legal Considerations for the Contemporary Life Sciences Industry - December 9-10, 2015
Enforcement, Litigation, & Compliance The Food and Drug Law Institute (FDLI) - October 15-16, 2015
ABA/MDMA/FDLI Medical Device Law 2015 - October 1-2, 2015
Advertising and Promotion for the Pharmaceutical, Medical Device, Biological, and Veterinary Medicine Industries, The Food and Drug Law Institute - July 16, 2015
ABA's FDA Drug Law Fundamentals, Webinar - November 12, 2014
ABA's Off-label Marketing and Free Speech: Caronia and the Future of Speech in Therapeutic Product Promotion webinar - September 10, 2014
Presentation to Mansfield-PhRMA Fellows: How U.S. Law Firms Help Their Clients Bring Pharmaceuticals and Biologics to Market - May 18, 2014
ATA Telemedicine Venture Summit 2014 - May 6, 2014
Executive Roundtable Series: New Frontiers in Health Care and Life Sciences; A Look at the Legal Implication - February 20, 2014
The Digital Health Revolution: How Law is Shaping the Next Frontier in Health Care Delivery, Health Law and Justice Society - November 13, 2013
2013-2014 Life Sciences Webinar Series: Intellectual Property, Regulatory, and Antitrust Issues in Life Sciences M&A and Capital Markets Transactions - October 24, 2013
FDA Fundamentals: FDA Drug Approval and Oversight, American Bar Association - September 11, 2013
Healthcare Technology Approvals, Clearances and Commercialization, Angel Venture Forum’s Cyber Security & Healthcare Investment Conference - August 1, 2013
Successfully Navigating FDA Citizen Petitions and Responses
- The Johns Hopkins University (Master of Public Health 2006); The George Washington University (J.D. with honors 2002); Lycoming College (B.S. in Biology, with dual minors in Chemistry and Environmental Science, summa cum laude 1999)
- District of Columbia, California, U.S. District Court for the District of Columbia, and U.S. Supreme Court
Named one of four "Rising Stars" in health law (2012) and in life sciences law (2014) by Law360
Elected to the Fellows of the American Bar Foundation (2018)
Board of Trustees, Lycoming College
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