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Advertising & Promotion

  • Apr 7, 2014
    Ark. Supreme Court Nullifies $1.2 Billion Award Over Drug Claims, Sends Case Back to Circuit Court
  • Apr 7, 2014
    FDA's 2015 Budget Proposal Seeks $17 Million To Review Prescription Drug Promotions
  • Apr 3, 2014
    CVM Issues Rare Promotion-based Advisory Action Letter
  • Mar 24, 2014
    Arkansas Supreme Court Nullifies $1.2 Billion Risperdal Award to State, Finding Misreading of Law
  • Mar 19, 2014
    Court Orders Supplement Maker To Pay $2.19 Million Over Bogus Diabetes Claims
  • Mar 19, 2014
    Court Orders Supplement Maker To Pay $2.19 Million Over Bogus Diabetes Claims
  • Mar 14, 2014
    Warning Letter Blasts Device Maker for Web Claims
  • Mar 12, 2014
    OPDP Hits Drug Maker Over Promotional Claims on Facebook
  • Mar 7, 2014
    Aegerion Plans Corrective Advertising Effort, Warns DOJ Investigation May Prove Costly
  • Mar 5, 2014
    FDA Updates Off-label Guidance, Adds CPGs to Allowed Texts
  • More

Good Clinical Practice

  • Feb 27, 2016
    DOE Issues Guidance on Classified Human Subject Research
  • Feb 25, 2016
    Goldwater Institute Calls for Congressional Changes for Compassionate Use
  • Feb 25, 2016
    W. Va. Senate Approves ‘Right-to-Try’ Bill
  • Feb 25, 2016
    Tuskegee and Lilly Work on Plan To Increase African American Trial Participation
  • Feb 24, 2016
    Dr. Robert M. Califf Confirmed by Senate as New Commissioner of Food and Drugs
  • Feb 24, 2016
    Ohio House Approves ‘Right-to-Try’ Bill
  • Feb 22, 2016
    NIH Estimates One-third of Trials Not Posting Required Results on ClinicalTrials.gov
  • Feb 19, 2016
    FDA Issues Revised Safety Data Collection Guidance
  • Feb 18, 2016
    Study Finds AMCs Doing ‘Poor’ Job of Disseminating Trial Results
  • Feb 18, 2016
    Two ‘Right-to-Try’ Bills Introduced Last Year Make Progress
  • More

FDA Regulation & Enforcement

  • Dec 6, 2018
    FDA Gives Go-Ahead to Oleic Acid, CHD Qualified Health Claim
  • Dec 5, 2018
    ev3 Inc. Pleads Guilty to Adulteration Charge Related to Off-Label Promotion of Neurovascular Device
  • Dec 5, 2018
    FTC Settles False Claims Case Against Nobetes
  • Dec 4, 2018
    Industry Group Calls for FDA Guidance on Communications About Biosimilar Products
  • Dec 1, 2018
    Philadelphia Considers Sales Rep Registration and Gift Ban
  • Nov 29, 2018
    Former Insys VP of Sales Pleads Guilty
  • Nov 28, 2018
    FDA Targets Dietary Supplements Containing Tianeptine Marketed as Opioid Use Disorder Treatments
  • Nov 27, 2018
    AMA Asks FDA for FOP Warning Labels for Added Sugars
  • Nov 21, 2018
    CDRH Report Highlights Link Between Increased Enforcement Activity and Stepped-Up Compliance
  • Nov 20, 2018
    In Advisory Opinion, OIG Says Providing Free Seizure Drug to Hospitals Would Raise Anti-Kickback Concerns
  • More

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