Frederick A. Stearns: Lawyer with Keller and Heckman LLP

Frederick A. Stearns

Partner
Washington,  DC  U.S.A.
Phone202.434.4288

Peer Rating
 4.4/5.0
BV® Distinguished

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Practice Areas

  • Biotechnology
  • Food & Drug
 
University Cornell University, B.S., 1988
 
Law SchoolGeorge Washington University Law School, J.D., with honors, 1993
 
Admitted1993, Virginia; 1995, District of Columbia
 
Biography

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

Dec 22, 2008 Keller and Heckman LLP Schedules Annual Practical Food Law Program
Jan 26, 2011 Partner Frederick Stearns Quoted in Anesthesiology News Article
Oct 03, 2011 Partner Rick Stearns Quoted in Guidance Underscores FDA Practice of Letting TEAs Steep Article
Dec 21, 2011 Partner Rick Stearns Quoted in Article on FDA Warning to Advertisers of Lap-Band Surgery
Jun 12, 2012 Partner Frederick Stearns to Speak at Plastics in Medical Devices 2012 Conference
Jun 01, 2012 Partner Frederick Stearns Quoted in Article on Generic Drug Warnings
Jun 18, 2012 Partner Frederick Stearns Quoted in Article on Breast Implant Study's Impact on Litigation
Sep 11, 2012 Frederick Stearns Presented at the MedTech Polymers 2012 Conference
Oct 19, 2012 Rick Stearns to Present at the American Conference Institute
Feb 01, 2013 Rick Stearns to Present at the Third Annual Life Science Chief Executive Officer Forum
Feb 01, 2013 Rick Stearns Will Make a Presentation at the Third Annual Life Science Chief Executive Officer Forum
Apr 04, 2013 Rick Stearns will speak at the Food and Drug Law Institute: Introduction to Drug Law and Regulation
May 01, 2013 Rick Stearns will speak at the Defoamer Industry Trade Association Annual Meeting
May 15, 2013 Rick Stearns Will Speak at the Parenteral Drug Association 2013 PDA/FDA Container Closure Components and Systems Workshop
Jun 27, 2013 Rick Stearns to Speak at the American Conference Institute: The Legal, Regulatory and Compliance Forum on Dietary Supplements
Apr 29, 2013 Rick Stearns Was Quoted in Recent Law360 Article
Oct 14, 2013 Rick Stearns to Present at the MedTech Polymers 2013 Conference
Oct 30, 2013 Rick Stearns to Present at the American Conference Institute's Second Annual Legal, Regulatory and Compliance Forum
Sep 10, 2013 Rick Stearns to Speak at FDLI's Safeguarding the Functional Food and Dietary Ingredient Supply Chain Conference
Feb 05, 2014 Rick Stearns to Present a Webinar: Understanding FDA's Inspection Authority and Access to Company Records

Events

Jan 24, 2007 Introduction to Medical Device Law and Regulation: Understanding How FDA Regulates the Medical Device Industry
Oct 22, 2007 Second Annual FDA Inspections Summit - Getting it Right the First Time, Every Time
Nov 09, 2007 Introduction to Drug Law and Regulation
Aug 07, 2007 FDA's Final Regulations on Current Good Manufacturing Practice (cGMP) for Dietary Supplements
Oct 16, 2007 Practical Food Law
Mar 10, 2008 Practical Food Law
Feb 11, 2008 Global Legislative Trend Overview & Analysis of Nanomaterials & Nanotechnologies
Feb 21, 2008 FDA's New Adverse Event Reporting Requirements -- What All OTC Drug Manufacturers Need to Know
May 29, 2008 American Conference Institute (ACI) FDA Boot Camp: Basic Training for Products Liability and Patent Lawyers
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
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
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
May 26, 2010 Keller and Heckman to Co-Sponsor: Preparing for FDA Inspection
Mar 21, 2011 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 19, 2012 Registration is closed - March 19-22, 2012- Keller and Heckman's Annual Practical Food Law Program, San Francisco, California
May 15, 2012 Registration is Closed - How to Manage the Regulatory Hurdles of TSCA and FDA - Indianapolis, IN - May 15-16, 2012
Apr 01, 2014 Practical Food Law Seminar - San Francisco, CA - April 1-3, 2014
Nov 22, 2013 Rick Stearns to Present a Webinar: Understanding the Scope of FDA's Inspection Authority and Its Ability to Access Company Records
Feb 21, 2014 Rick Stearns to Present at American Conference Institute (ACI)
May 06, 2014 TSCA & FDA Seminar - Indianapolis, IN
Feb 05, 2014 Rick Stearns to Present a Webinar: Understanding FDA's Inspection Authority and Access to Company Records

Articles

Apr 25, 2014 Food and Drug Alert
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
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

 
ISLN900647169
 

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Notable Provisions of H.B. 112
Melvin S. Drozen,Leslie T. Krasny,Eric S.C. Lindstrom,Richard F. Mann,Frederick A. Stearns, April 30, 2014
Section 3403 sets forth the GMO labeling requirements in Vermont. Foods that are produced entirely or partially with genetic engineering must be labeled as follows:

FDA Announces Major Revisions to the Nutrition and Supplement Facts Labels
Melvin S. Drozen,Leslie T. Krasny,Eric S.C. Lindstrom,Richard F. Mann,Frederick A. Stearns, March 5, 2014
Today, the Food and Drug Administration (FDA) announced the availability of three proposed rules that would revise the Nutrition Facts label requirements. These proposals will be published in the Federal Register on Monday, March 3.


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Office Information

Frederick A. Stearns

Suite 500 West, 1001 G Street, N.W.
WashingtonDC 20001




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