Diane C. McEnroe

Diane C. McEnroe

[email protected]

Diane C. McEnroe is a partner in Sidley’s New York office. Diane has established long-standing relationships with domestic and international companies in the food, drug, medical device, and personal care industries. As a member of Sidley’s Food, Drug and Medical Device Regulatory practice, she provides strategic counsel on Food and Drug Administration regulatory questions on a broad range of issues, including product formulation and positioning, ingredient safety, claims substantiation, over-the-counter drug monograph issues, and post-marketing obligations, including adverse event reporting and food registry postings. Diane also has extensive experience advising on drug sampling programs, track and trace systems, and state licensure issues. She supports clients in responding to Warning Letters, during facility inspections and recalls, and in addressing product integrity issues. In addition to her FDA advisory role, Diane has also assisted clients with FTC investigations relating to consumer products. With her deep knowledge of foods, including functional and medical foods, and dietary supplements, Diane has guided clients through the implementation of significant legislative amendments, and she regularly trains in-house counsel and regulatory teams on FDA compliance issues. Diane’s leadership has earned her recognition The Legal 500 US, Who’s Who Legal: Life Sciences, and The Best Lawyers in America.

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