We guide products from start to finish through the Food and Drug Administration (FDA) pre-market clearance process, beginning with product development strategies designed to minimize FDA regulatory costs and avoid time delays.

We work with our clients to respond to and negotiate with the FDA as issues arise during the FDA clearance process, and we also provide advice regarding the FDA's requirements for labeling, advertising, manufacturing, imports and exports.

Representative Matters:

• Worked with companies regarding the development and distribution of drugs, devices, biologics, orphan drugs, food, food additives, animal feeds and cosmetics
• Obtained Congressional report language directing FDA to expedite approval of a new class of veterinary drugs called competitive exclusion products
• Secured FDA clearance of cranial orthosis through premarket notification process
• Secured FDA clearance of multiple models of a circulatory assist device manufactured by a British company
• Secured FDA clearance of multiple models of a wheelchair designed for the severely disabled
• Secured FDA clearance of a computerized telemedicine device manufactured by a small device company
• Assisted a client in responding to an FDA inspection and a subsequent warning letter regarding compliance with FDA good manufacturing practice standards
• Prepared labeling for nutritional supplement products in compliance with FDA labeling standards
• Assisted a client in organizing clinical trials involving investigational lithotripters and strategies on how to bill for related services