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.
News, Events & Articles
News
Jun 12, 2012, Partner Frederick Stearns to Speak at Plastics in Medical Devices 2012 Conference
Dec 21, 2011, Partner Rick Stearns Quoted in Article on FDA Warning to Advertisers of Lap-Band Surgery
Oct 03, 2011, Partner Rick Stearns Quoted in "Guidance Underscores FDA Practice of Letting TEAs Steep" Article
Jan 26, 2011, Partner Frederick Stearns Quoted in Anesthesiology News Article
Dec 22, 2008, Keller and Heckman LLP Schedules Annual Practical Food Law Program
Events
May 15, 2012, Register Today - How to Manage the Regulatory Hurdles of TSCA and FDA - Indianapolis, IN - May 15-16, 2012
Mar 19, 2012, Register Today : March 19-22, 2012- Keller and Heckman's Annual Practical Food Law Program, San Francisco, California
May 24, 2011, Register Today! What U.S. Companies Need to Know: How to Manage the Regulatory Hurdles of TSCA, FIFRA & FDA
May 05, 2011, Hot Topics and Emerging Trends in the Medical Device Industry
Mar 21, 2011, Keller and Heckman's Annual Practical Food Law Program, San Francisco, California
May 26, 2010, Keller and Heckman to Co-Sponsor: Preparing for FDA Inspection
Apr 06, 2009, International Pharmaceutical Academy: Medical Device Regulations & Law - Addressing the Changing Regulatory and Legal Environment
Mar 16, 2009, GTCbio's 4th Annual Imaging in Clinical & Pre-clinical Drug Development Conference
Nov 21, 2008, Food and Drug Law Institute's Introduction to Drug Law and Regulation conference
Nov 10, 2008, Medical Device Regulations & Law - Addressing the Changing Regulatory and Legal Environment
Jun 09, 2008, American Conference Institute (ACI's) 2nd Annual In-House Counsel Forum on Manufacturing, Marketing and Distributing Dietary Supplements, Nutraceuticals and Functional Foods
May 29, 2008, American Conference Institute (ACI) FDA Boot Camp: Basic Training for Products Liability and Patent Lawyers
Mar 10, 2008, Practical Food Law
Feb 21, 2008, FDA's New Adverse Event Reporting Requirements -- What All OTC Drug Manufacturers Need to Know
Feb 11, 2008, Global Legislative Trend Overview & Analysis of Nanomaterials & Nanotechnologies
Nov 09, 2007, Introduction to Drug Law and Regulation
Oct 22, 2007, Second Annual FDA Inspections Summit - Getting it Right the First Time, Every Time
Oct 16, 2007, Practical Food Law
Aug 07, 2007, FDA's Final Regulations on Current Good Manufacturing Practice (cGMP) for Dietary Supplements
Jan 24, 2007, Introduction to Medical Device Law and Regulation: Understanding How FDA Regulates the Medical Device Industry
Articles
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
Aug 02, 2011, June 2011 National Academies Meeting On Sustainable Development of Algal Biofuels Highlights Water Consumption at Commercial Scale
Jul 07, 2011, FDA Publishes Long-Awaited Draft Guidance Document on New Dietary Ingredients for use in Dietary Supplements
Jun 10, 2011, FDA Issues Draft Guidance on Nanotechnology
Jan 03, 2011, Advertising and Food and Drug Law Report: Consent Orders Provoke Debate Over FTC and FDA Substantiation Standards
Nov 08, 2010, FDA Due Diligence - An Ounce of Prevention...
Apr 22, 2009, Wyeth v. Levine - U.S. Supreme Court Rejects FDA Preemption in Pharmaceutical Cases
Feb 27, 2008, FDA Preemption Alert - New Product Liability Cases Focus on FDA's Mission
Aug 08, 2007, FDA Publishes Final Rule on Current Good Manufacturing Practices (cGMPs) for Dietary Supplements
Feb 15, 2007, New Legislation Requires Submission to FDA of Serious Adverse Event Reports (SAERs) for Dietary Supplements and Over-the-Counter (OTC) Drug Products
Nov 11, 2005, Appeals Court Upholds Remedy of Consumer Restitution in FDA Dietary Supplements Enforcement Action
May 25, 2005, Biotechnology/Nanotechnology Alert
Apr 20, 2005, Federal Court Limits FDA's Ephedra Ban and Severely Questions the Standard for Finding That Dietary Supplements Present an "Unreasonable" Risk of Illness or Injury
Jan 14, 2005, Institute of Medicine (IoM) Report on Dietary Supplements Paints an Incomplete Picture of the Regulatory Framework
Nov 12, 2004, FDA Announces New Dietary Supplement Regulatory Enforcement Strategy
Nov 12, 2004, FDA Releases Draft Guidance for Industry on Substantiation Needed for Dietary Supplement Structure/Function Claims
Feb 23, 2004, FDA Issues Final Rule Prohibiting Sale of Dietary Supplements Containing Ephedrine Alkaloids (Ephedra); First Use of Statutory Authority
May 14, 2003, FDA Considers Rx-to-OTC Switch of Antihistamine Drug Products
May 13, 2003, FDA Proposes Regulations on Current Good Manufacturing Practices (cGMPs) in Manufacturing, Packing, or Holding Dietary Supplements and Dietary Ingredients
Feb 20, 2002, FDA Issues Final Rule on the Use of Foreign Marketing Experience to Support Over-the-Counter (OTC) Drug Status in the U.S.
Dec 18, 2001, FDA Establishes New Policy on OTC Drug Inactive Ingredient Labeling
May 18, 2000, FDA Extends Over-the-Counter (OTC) Drug Labeling Compliance Date
Oct 13, 1999, FDA Pediatric Rule Affects ANDA Suitability Petitions
Nov 03, 1998, FDA Dental Plaque Advisory Panel Issues Draft Report
May 14, 1998, FDA Seeks Comments on Revised Draft of Guidance Document for API Manufacturers
Mar 14, 1998, GMPs for Bulk Pharmaceutical Chemical Manufacturers: FDA Is Becoming More Demanding