Justin Mann

Justin Mann is an associate with the Health Care Group and a member of the Food & Drug Team. A major component of Justin’s practice includes assisting clients in addressing concerns expressed by the FDA, whether through inspection observations, warning letters, regulatory meetings, or requests for information.

From conducting inspection readiness activities to providing backroom support at foreign sites to analyzing scientifically complex documents for responses, Justin provides a full range of services to clients.

Justin provides regulatory counsel on FDA-related components of promotional materials, securities filings, and due diligence. Justin assists clients with issues that arise during the course of drug development, such as adverse event reporting and complications with marketing applications.

Justin received his J.D., with honors, from the University of North Carolina School of Law, where he was managing editor of the North Carolina Journal of Law & Technology. He graduated from Elon University, magna cum laude, with a B.A. in psychology.

Before joining Alston & Bird, Justin spent nearly a decade in the health care industry. He held various audit and compliance roles for a global pharmaceutical company, where he drafted risk mitigation plans, developed compliance programs using the OIG’s seven fundamental elements of an effective compliance program, and conducted trainings. He also has experience at academic medical centers.

Bar Admissions:

•  District of Columbia
•  North Carolina

Education:

•  University of North Carolina (J.D., 2014)
•  Elon University (B.A., 2007)

EXPERIENCE:

• Assisting clients subject to FDA enforcement to respond to warning letters, Form 483s, and RFIs.
• Part of a team that conducted an internal investigation into claims made by the FDA regarding delaying, denying, limiting, or refusing an inspection.
• Assisted a criminal investigation team by providing review and analysis of technical analytical reports.
• Conducting FDA-related due diligence for large acquisitions, including reviewing compliance programs, promotional materials, physician compensation, and federal and state facilities registrations.
• Reviewing promotional materials and medical affairs materials for both pre-market and approved products.