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.
•Aug 29, 2016 Summaries on FDA's Final Rule on GRAS Notices and the Draft Guidance Document on New Dietary Ingredient Issues
•Jul 24, 2015 FDA Announces Supplemental Proposal to the Nutrition and Supplement Facts Labels
•Apr 25, 2014 Vermont Legislature Passes GMO Labeling Bill
•Feb 27, 2014 FDA Announces Major Revisions to the Nutrition and Supplement Facts Labels
•Aug 15, 2013 FDA Issues Revised Draft Guidance on Medical Foods
•Jun 26, 2012 Form 483s Can be Material Under Federal Securities Law
•Mar 05, 2012 FDA Publishes Three New Draft Guidance Documents on Biosimilar Product Development
•Sep 22, 2016 Rick Stearns to Present Understanding the Clinical Trial Process for Drugs and Biologics
•Sep 17, 2016 Rick Stearns Will Present An Overview of FDA's Abbreviated New Drug Application (ANDA) Requirements
•Jan 28, 2016 Partner Rick Stearns to Serve on Panel at the New York State Bar Association's Annual Meeting of the Food, Drug and Cosmetic Law Section
•Mar 04, 2015 Rick Stearns to Present at ACI's Legal, Regulatory & Compliance Forum on Cosmetics
•Feb 25, 2015 Rick Stearns to Present a Webinar: General Wellness Products - How to Make the FDA's New Policy Work For You
•Feb 24, 2015 Rick Stearns to Present at FDLI's Introduction to Food Law and Regulation Conference
•Feb 05, 2014 Rick Stearns Presents a Webinar: Understanding FDA's Inspection Authority and Access to Company Records
•May 02, 2017 The Connected Product Intensive: A Framework for Regulatory Compliance and Risk Management Seminar
•Mar 29, 2016 Webinar: Know Your Food Suppliers - New FSMA Responsibility, Liability, and Insurance
•May 06, 2014 TSCA & FDA Seminar - Indianapolis, IN