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J. Lee  Gray, Esq.

Lee Gray is a partner with Holland & Hart LLP’s Denver office. Lee helps manufacturing clients, and particularly medical device, pharmaceutical and other FDA-regulated companies, handle a variety of product-related issues, including regulatory compliance, product labeling, facility inspections, product recalls, product liability litigation, class actions, and resolving commercial disputes. Lee represents manufacturers from regulated industries in dealing with governmental agencies, including FDA, USDA, FTC, and CPSC, as well defending manufacturers in litigation matters.

Programs by J. Lee  Gray, Esq..

In addition to evaluating data from adverse event reports, the bulk of FDA's regulatory enforcement comes from its facility inspections and resulting 483 reports. Such regulatory enforcement actions not only carry financial risks of regulatory non-co...

Program Number
30210
Program Date
2020-09-01
Category
Biotechnology & Life SciencesBusiness Organizations & ContractsConstitutional LawDispute ResolutionFederal CourtsFlorida EligibleHealth Care LawPharmaceutical LawRegulatory and Administrative Law
State
CaliforniaFloridaGeorgiaNew JerseyNew YorkTexas Self Study