Partner at Keller and Heckman LLP
Frederick (Rick) Stearns is a partner in the law firm of Keller and Heckman LLP in Washington, DC. For the past 27 years, he has worked on a wide range of issues facing manufacturing of prescription and over-the-counter drugs, medical devices, dietary supplements, food, and cosmetics. He 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, communicate with Agency officials, and develop innovative strategies to deal with evolving FDA regulatory requirements. In addition, Rick 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.
On April 7, Rick presented an overview of the FDA regulatory requirements facing manufacturers and marketers of drugs and medical devices in the United States.
Theme: The Life Science Ecosystem in the U.S.