Our Drug and Medical Device practice delivers regulatory know-how with value added by the scientific expertise of our intellectual property practice. Unlike most "FDA practices," we have a unique technical capacity that comes from our world-class patent practice. One-stop shopping for both patents and regulatory work saves client resources because clients need not teach their technology twice.

We have experience in a wide range of FDA regulation of various products, including small molecule drugs, biologics, homeopathics, and medical devices. We counsel clients in areas such as gene and cell therapies, antihypertensives, ophthalmics, anti-inflammatories, immunologics, antibiotics, anti-anxiety medications, hormone therapies, and medical gases. Our medical device practice covers products such as research and screening technologies, dental devices, implants, imaging agents, medical telemetry, PARS, catheters, cardiovascular devices, microwave therapies, pressure monitors, oximeters, and various types of drug delivery technologies. We also are experienced in a broad range of radiological health technologies including x-ray, MRI, PET, and medical lasers.

One of our unique specialties is advising on the interrelationship between patent and drug laws to protect patent exclusivity for products worldwide. In the United States, this means understanding the complex relationship between U.S. patent laws and the Drug Price Competition and Patent Term Restoration Act of 1984 ("Hatch-Waxman Act"). We advise and counsel clients on the scope and application of the 271(e)(1) safe harbor from patent infringement; Orange Book practice and patent litigation under 271(e)(2); marketing exclusivities for pioneers and generics; and patent term extensions.

• Drug and Biologic Regulation
• Hatch-Waxman, Orphan Drugs, and Pediatric Exclusivity
• Medical Device Approvals and Compliance
• FDA at the border: Import and Import Regulations for Medical Devices