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Advertising & Promotion

  • Oct 18, 2016
    Company Will Discontinue Claims Challenged in NAD Inquiry
  • Oct 12, 2016
    District Court Rejects ‘Good Faith’ Defense
  • Oct 11, 2016
    CMS Clarifies Rules on Reporting CME Payments and Support
  • Oct 7, 2016
    ‘Off-label’ Issues Move from Marketing to Access and Reimbursement
  • Oct 7, 2016
    Supplement Marketer Settles FTC Charges of Deceptive Advertising, Endorsements
  • Oct 6, 2016
    Novartis Settles Off-Label Marketing Case With Feds and Eight States for $35 Million
  • Oct 6, 2016
    Former Insys Sales Rep Arrested, Charged with Health Care Fraud Linked to Speaker Programs
  • Oct 6, 2016
    NAD Refers Two Medical Ads to FTC
  • Oct 5, 2016
    District Court Allows Chicago Suit Against Opioid Makers To Continue
  • Oct 4, 2016
    How FDA Can Reform Off-Label Promotion Priorities
  • More

Good Clinical Practice

  • May 20, 2017
    CRS Files Amendment on Citizen Petition Regarding Preclinical Testing
  • May 19, 2017
    CTTI Issues Recommendations for Using Patient Registries To Enhance Clinical Trials
  • May 18, 2017
    Eight Research Funders Agree to Register Studies and Disclose Results
  • May 18, 2017
    FDA ORA Realignment Adds New BIMO Office
  • May 12, 2017
    What To Do About Nonfinancial Conflicts?
  • May 11, 2017
    FDA Gears Up To Implement Device Provisions of Cures Act With Proposed Work Plan
  • May 9, 2017
    Gottlieb Confirmed by Senate as New FDA Commissioner
  • May 9, 2017
    Senate Bill Considers Expanded Access
  • May 3, 2017
    Bill Directs HHS To Evaluate Distress Experienced by Trial Subjects
  • May 3, 2017
    FDA and NIH Release Final Protocol Template; NIH Provides E-Writing Tool
  • More

U.S. Food Labeling

  • Aug 31,2010
    Preemption, Puffery Arguments Fail To Derail Case Against Vitaminwater
  • Jul 31,2010
    Lawsuit Against Coke's Vitaminwater To Proceed
  • Jul 31,2010
    Product Recalls
  • Jul 31,2010
    Comments on 2010 Dietary Guidelines' Report Reflect Wide Range of Opinion
  • Jul 31,2010
    FDA Seeks Public Comment on New Federal Menu Labeling Law for Chain Restaurants
  • Jul 31,2010
    General Mills Sued over Claims for Fruit Snacks
  • Jul 31,2010
    FTC Settlement with Nestlé over Probiotics Contains New Substantiation Standard
  • Jun 30,2010
    Lawsuit Against Unilever's 'I Cannot Believe It's Not Butter' Claims Dismissed by U.S. Court
  • Jun 30,2010
    Product Recalls
  • Jun 30,2010
    2010 Dietary Guidelines To Target Obesity Epidemic; Sodium Reduction Also Recommended by Panel
  • More

FDA Regulation & Enforcement

  • Oct 17, 2019
    Physicians’ Group Wants FDA To Require Label on Cheese Warning of Possible Link to Breast Cancer
  • Oct 16, 2019
    Court Grants DOJ’s Motion To Dismiss False Claims Kickback Allegations Against Drug Manufacturers
  • Oct 15, 2019
    Mylan $30 Million Settlement Resolves SEC Allegations of Failing To Disclose DOJ EpiPen Investigation
  • Oct 12, 2019
    Appeals Court Rejects Delay of Bellwether Opioid Trial
  • Oct 10, 2019
    Two Companies, Two Officials Plead Guilty to Refusing To Allow FDA Inspections at Ohio Facilities
  • Oct 9, 2019
    AMS Renews Various Substances on Organic Program’s National List
  • Oct 4, 2019
    Survey Finds Fewer U.S. Physicians Have In-person Meetings with Pharma Reps
  • Oct 3, 2019
    First Warning Letters Issued Jointly by FDA and DEA Target Online Networks Marketing Illegal Opioids
  • Oct 3, 2019
    AMS Posts New BE Food Disclosure FAQs, Decision Tree
  • Oct 2, 2019
    District Court Dismisses Whistleblower Case Over AbbVie Ambassador Program
  • More

Medical Devices

  • Feb 4, 2013
    Full 9th Circuit Reverses Appeals Court Panel, Holding Failure-To-Warn Claim Is Not Preempted
  • Jan 31, 2013
    FDA Issues Final cGMP Rule for Combination Products
  • Jan 14, 2013
    FDA Asks for Input on Device Submission Review Assessment
  • Jan 14, 2013
    Eye Surgery Promotions Result in Warning Letters
  • Jan 14, 2013
    Draft Guidance Addresses Home Use Device Design
  • Jan 14, 2013
    Consent Decree Imposes Mandates on Invacare Corp.
  • Jan 14, 2013
    Centers Finalize Three Device Guidance Documents
  • Dec 14, 2012
    Consortium Seeks To Advance Regulatory Science for Devices
  • Dec 14, 2012
    FDA Prioritizes Guidance Document Development for FY 2013
  • Dec 14, 2012
    CDRH Trumpets Device Review Time Improvements
  • More

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