Frederick Stearns joined Keller and Heckman in 1993. His 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.
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Aug 15, 2013 FDA Issues Revised Draft Guidance on Medical Foods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Mar 05, 2012 FDA Publishes Three New Draft Guidance Documents on Biosimilar Product Development
Nov 29, 2011 FDA Seeks First Injunction Against Dietary Supplement Companies
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
Oct 30, 2013 Rick Stearns Presents at the American Conference Institute's Second Annual Legal, Regulatory and Compliance Forum
Oct 14, 2013 Rick Stearns Presents at the MedTech Polymers 2013 Conference
Sep 10, 2013 Rick Stearns Speaks at FDLI's Safeguarding the Functional Food and Dietary Ingredient Supply Chain Conference
May 06, 2014 TSCA & FDA Seminar - Indianapolis, IN
Apr 01, 2014 Practical Food Law Seminar - San Francisco, CA - April 1-3, 2014
Feb 21, 2014 Rick Stearns to Present at American Conference Institute (ACI)
Feb 05, 2014 Rick Stearns to Present a Webinar: Understanding FDA's Inspection Authority and Access to Company Records
Nov 22, 2013 Rick Stearns to Present a Webinar: Understanding the Scope of FDA's Inspection Authority and Its Ability to Access Company Records
May 15, 2012 Registration is Closed - How to Manage the Regulatory Hurdles of TSCA and FDA - Indianapolis, IN - May 15-16, 2012
Mar 19, 2012 Registration is closed - March 19-22, 2012- Keller and Heckman's Annual Practical Food Law Program, San Francisco, California