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Advertising & Promotion

  • Nov 29, 2016
    Digital Marketing Continues to Increase
  • Nov 28, 2016
    First Circuit Affirms Dismissal of False Claims Suit Based on Alleged Actos Off-Label Marketing
  • Nov 18, 2016
    Chicago City Council Approves Licensing Drug Sales Reps
  • Nov 17, 2016
    FTC Will Treat OTC Homeopathic Drug Claims the Same as Claims for Other OTC Drug Health Products
  • Nov 16, 2016
    Positions Staked out on Impact of First Amendment on Manufacturer Communication on Off-label Uses
  • Nov 15, 2016
    FDA Commissioner Interest May Signal Some Marketing Guidance Coming Sooner Rather Than Later
  • Nov 11, 2016
    Alexion Announces Internal Investigation of Sales Practice for Company Drug
  • Nov 11, 2016
    FDA Permanently Debars Company Owner Over Marketing, Selling and Exporting Unapproved Drug
  • Nov 9, 2016
    Alleged Off-Label Promotion Results in Device Manufacturer’s Guilty Plea, $36 Million Settlement
  • Nov 9, 2016
    FDA To Test Whether Risk Data Links Are Effective
  • More

Good Clinical Practice

  • Jun 26, 2017
    FDA Provides Draft Guidance on Use of Mobile Technology in Clinical Investigations
  • Jun 26, 2017
    FDA Updates 2003 Draft Electronic Records Guidance
  • Jun 26, 2017
    FDA Workshop To Examine TB Trial Designs
  • Jun 26, 2017
    ORI Extends Researcher Remediation Program
  • Jun 19, 2017
    European Union’s Trial Regulation Delayed
  • Jun 17, 2017
    Checklist Issued for Applicable Trials
  • Jun 16, 2017
    Public Citizen Asks OHRP To Again Examine SUPPORT Trial
  • Jun 7, 2017
    ABPI Launches Research Database
  • Jun 7, 2017
    ICMJE Will Require Data Sharing Statement Starting in July 2018
  • Jun 7, 2017
    FDA Drops ‘Local’ from IRB Review Regulations as Mandated by 21st Century Cures Act
  • More

U.S. Food Labeling

  • Nov 30,2010
    FTC Asks Court to Dismiss POM Wonderful Suit
  • Oct 31,2010
    FTC Complaint Charges POM Wonderful with Making Deceptive Disease Prevention Claims
  • Oct 31,2010
    House Bill Targets Labeling of Biotech Salmon
  • Oct 31,2010
    FDA Creates Qualified Health Claims for Selenium
  • Oct 31,2010
    IOM Picks Calories, Saturated Fat, Trans Fat and Sodium for Inclusion on FOP Label
  • Oct 31,2010
    FDA Declines To Provide Courts with Guidance on Whether HFCS Qualifies as 'Natural' Ingredient
  • Oct 31,2010
    Product Recalls
  • Oct 31,2010
    Federal Appeals Court Rules against Ohio's Ban on 'rbGH Free' Label Claims
  • Sep 30,2010
    Corn Refiners Petition FDA To Approve 'Corn Sugar' as Alternate Name for HFCS
  • Sep 30,2010
    FDA Issues Guidances Containing Details on New Federal Menu Labeling Requirements
  • More

FDA Regulation & Enforcement

  • Nov 6, 2019
    OPDP Researchers To Examine Understanding of Terms and Phrases Used in Drug Promotion
  • Nov 4, 2019
    Point of Care Media Provide Verification And Validation Requirements
  • Nov 4, 2019
    Former Sales Rep Pedals Compounded Drugs Illegally
  • Nov 4, 2019
    Virginia Sues Teva Over Fentanyl Marketing
  • Nov 4, 2019
    Dr. Stephen Hahn Named as Next FDA Commissioner; Sharpless Returns to National Cancer Institute
  • Nov 1, 2019
    Media Company To Pay $70 Million for Selling Non-existent Ads
  • Oct 31, 2019
    ’Imitation’ Meat Labeling Act Introduced on Capitol Hill
  • Oct 30, 2019
    Wholesaler CEOs Indicted in Connection with Alleged Scheme To Divert Prescription Pharmaceuticals
  • Oct 28, 2019
    Two Foundations To Pay $6 Million To Resolve Kickback Allegations Involving Co-Pays
  • Oct 28, 2019
    FTC Releases Proposed Consent Agreement Over Employee-written Online Product Reviews
  • More

Medical Devices

  • May 9, 2013
    FDA Issues Draft Guidance on Use of ISO 10993
  • May 9, 2013
    CDRH Releases Update on Postmarket Surveillance Initiative; Shuren Offers Vision of New System
  • May 1, 2013
    Court Affirms FDA’s Authority To Rescind 510(k) SE Determination Within ‘Reasonable’ Period of Time
  • Apr 24, 2013
    FDA Proposes Allowing Recognized Standard Stand-alone Symbols in Device Labeling
  • Apr 18, 2013
    Guidance Explains Device Classification Product Codes
  • Apr 10, 2013
    CDRH Calls for Experiential Learning Program Participants
  • Apr 10, 2013
    Device Center Schedules Workshop on Computer Modeling, Simulation
  • Apr 4, 2013
    Guidances Outline User Fees for Device Submissions
  • Mar 28, 2013
    OIG Alert Targets Physician-Owned Distributorships
  • Mar 27, 2013
    D.C. Circuit Upholds FDA’s SE Determination for Two Cytori Devices Used To Harvest Stem Cells
  • More

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