James Czaban

James "Jim" Czaban is a prominent FDA regulatory and compliance lawyer with over 30 years of experience in government regulation of pharmaceuticals, biotechnology, food, dietary supplements, and medical devices.2 He is currently a Partner in the Life Sciences and FDA Regulatory Group at Loeb & Loeb LLP.12

As a leading authority in his field, Czaban focuses on:

1. FDA regulatory strategies and compliance matters
2. Representing clients in administrative and judicial enforcement actions
3. Proceedings involving the FDA, FTC, DEA, DOJ, and other federal and state agencies1

Czaban is recognized for his expertise in several key areas:

• Hatch-Waxman Amendments and the Biologics Price Competition and Innovation Act (BPCIA)
• Drug product exclusivities and innovation incentives
• Drug marketing and promotion
• FDA's Orange Book and patent listing requirements
• Regulatory aspects of "Paragraph IV" patent challenges
• Lifecycle management strategies1

His clients include pharmaceutical, biotechnology, food, medical device, and life sciences companies. Czaban is known for his creative problem-solving abilities and practical approach to complex regulatory issues.1

In addition to his legal practice, Czaban is actively involved in the industry:

• Legal columnist and Editorial Board member for the Journal of Precision Medicine
• Member of the Bloomberg Law Advisory Board for Pharmaceuticals and Life Sciences
• Member of the Food & Drug Law Institute (FDLI)1

Czaban frequently shares his expertise through professional activities:

• Moderating panels on FDA regulations, such as the FDA's "intended use" rule5
• Contributing to industry publications, including a chapter on FDA Enforcement in FDLI's "How FDA Really Works" treatise4
• Commenting on FDA-related developments, such as online drug and device promotion regulations3

His LinkedIn username is fdalaw, where he regularly posts updates and insights on FDA regulatory matters.2345