Frederick Stearns' practice involves a wide range of issues affecting manufacturing of prescription and over-the-counter drugs, medical devices, dietary supplements, and cosmetics.
Mr. Stearns helps product manufacturers evaluate the need for marketing approval from FDA, to pursue appropriate clearance when necessary, and address regulatory compliance issues with marketed products (including OTC drug monographs, product labeling and promotion, and current good manufacturing practices). He also works with clients to respond to FDA enforcement activities, navigate the interrelationship of the patent laws and the FDA drug approval process, communicate with Agency officials, and develop innovative strategies to deal with evolving FDA regulatory requirements. In addition, Mr. Stearns has worked with numerous companies to conduct FDA due diligence reviews, both for internal control purposes and as part of product line or corporate acquisitions.
Mr. Stearns is a frequent speaker at conferences on the legal issues involving the regulation of drugs, medical devices, and dietary supplements.
