Frederick A. Stearns

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Aug 29, 2016 Summaries on FDA's Final Rule on GRAS Notices and the Draft Guidance Document on New Dietary Ingredient Issues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Aug 15, 2013 FDA Issues Revised Draft Guidance on "Medical Foods"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
Mar 05, 2012 FDA Publishes Three New Draft Guidance Documents on Biosimilar Product Development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Jul 07, 2011 FDA Publishes Long-Awaited Draft Guidance Document on New Dietary Ingredients for use in Dietary Supplements
Jun 10, 2011 FDA Issues Draft Guidance on Nanotechnology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Nov 12, 2004 FDA Releases Draft Guidance for Industry on Substantiation Needed for Dietary Supplement Structure/Function Claims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
Mar 14, 1998 GMPs for Bulk Pharmaceutical Chemical Manufacturers: FDA Is Becoming More Demanding