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Julie K. Tibbets

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 Washington
T: 202-239-3444
F: 202-654-4944

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T: 202-239-3444
F: 202-654-4944

Julie Tibbets has built her practice around all aspects of FDA-regulated product development and marketing. Julie advises developers, manufacturers and marketers of FDA-regulated products on how to most effectively interact with the agency and minimize regulatory risks. She provides strategic counsel on product development plans and regulatory submissions and works closely with her clients’ in-house teams to build efficiencies and streamline regulatory processes. Her product reach spans biologics, drugs, medical devices, in vitro diagnostics (IVDs), foods, dietary supplements and cosmetics.

Julie’s core experience includes advising clients on product development pathways, investor and corporate communications, product labeling, advertising, employee training and interactions with health care professionals. She also counsels clients on adverse event reporting, recalls, product formulations, software and mobile app regulation, Sunshine Act reporting and inspection observation remediation.

Since 2013, Julie has appeared on the Washington, D.C., Super Lawyers list of “Rising Stars” in the FDA area and was selected by her peers for inclusion in The Best Lawyers in America© 2016 and 2017 for FDA law.