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Fish Cases

FDA and Hatch-Waxman experience

Fish Cases

FDA and Hatch-Waxman experience

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In-Depth

Experienced in a wide range of FDA product approvals including small molecule drugs, biologics, and medical devices. Client work includes gene and cell therapies, antihypertensives, ophthalmics, anti-inflammatories, immunologics, antibiotics, anti-anxieties, hormone therapies, and medical gases. Device work includes research and screening technologies, dialysis, dental devices, implants, imaging agents, medical telemetry, PARS, catheters, cardiovascular devices, microwave therapies, pressure monitors, oximeters, and various types of drug delivery technologies. Also experienced in x-ray, MRI, PET, and medical lasers.

Provides advice and counseling to clients on the scope and applications of 271(e)(1) safe harbor; Orange Book practice and patent litigation under 271(e)(2); marketing exclusivities for pioneers and generics; and patent term extensions.