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.
•Mar 14, 2019 Rick Stearns Quoted in Article on QC and Drug Manufacturing
•Dec 11, 2018 Rick Stearns Will Present Biomaterals Supplier Liability Issues - FDA Regulation and Managing Risk
•Jul 26, 2018 Rick Stearns Will Present FDA Enforcement and Compliance and International Issues
•Mar 08, 2018 Rick Stearns Will Present Exploring the Expedited Approval Process
•Mar 06, 2018 Rick Stearns to Present Imports and Intersections: Uncovering Common Challenges and Implementing Plans to Avoid Needless Delays
•Aug 15, 2017 Rick Stearns Will Present FDA Food Inspection and Enforcement Authority
•Jul 28, 2017 Rick Stearns to Present Device Recalls and Withdrawals at the American Conference Institute (ACI): 5th Annual FDA Boot Camp - Devices Edition
•Oct 25, 2017 Practical Food Law Seminar - Brussels, Belgium
•May 02, 2017 The Connected Product Intensive: A Framework for Regulatory Compliance and Risk Management Roundtable
•Mar 29, 2016 Webinar: Know Your Food Suppliers - New FSMA Responsibility, Liability, and Insurance
•May 06, 2014 TSCA & FDA Seminar - Indianapolis, IN
•Oct 05, 2017 FDA’s Meeting on Establishing a List of Pre-DSHEA Dietary Ingredients
•Aug 29, 2016 Summaries on FDA’s Final Rule on GRAS Notices and the Draft Guidance Document on New Dietary Ingredient Issues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•Aug 15, 2013 FDA Issues Revised Draft Guidance on Medical Foods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
•American Bar Association
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