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Advertising & Promotion

  • Jan 23, 2015
    Senator Pushes Bill Penalizing Big Drug Companies for Settling Federal Allegations
  • Jan 22, 2015
    Draft Device Guidance Ties Accessory Classification to Marketing Materials
  • Jan 14, 2015
    Daiichi Sankyo Pays $39 Million To Settle Kickback Allegations
  • Jan 13, 2015
    CVM Challenges Antibiotic Claims in Rare Warning Letter Over Promotion
  • Jan 13, 2015
    Planned Study on Shortened Major Statement Headed to OMB Review
  • Jan 7, 2015
    CDER Plans Six Advertising-specific Guidances for 2015
  • Dec 20, 2014
    FDA Planned Review of Off-label Policies Is ‘Front Burner’ Issue for CDER in 2015
  • Dec 18, 2014
    Untitled Letter Blasts Sunovion Over Efficacy Claims in Print Ad
  • Dec 9, 2014
    OtisMed, CEO Plead Guilty to Selling Thousands of Uncleared Surgical Devices
  • Dec 3, 2014
    Grand Jury Indicts Device Manufacturer, CEO, Alleging Off-label Marketing, Conspiracy To Defraud
  • More

Good Clinical Practice

  • Jun 18, 2016
    FDA Suggests Ways To Boost Subgroup Enrollment
  • Jun 18, 2016
    FDA Issues Draft Guidance on Evaluating and Reporting Age, Race, Ethnicity Data for Device Trials
  • Jun 17, 2016
    FDA and NIH To Conduct Pediatric Clinical Investigator Training in September
  • Jun 15, 2016
    Exclusion Criteria for Type 2 Diabetes Trials May Impede Enrollment of Women
  • Jun 15, 2016
    Survey Finds Less Resistance to Trial Subjects Using Own Devices for PRO
  • Jun 14, 2016
    FDA Posts Videos To Launch Program Encouraging Minority Trial Participation
  • Jun 14, 2016
    Researchers Find Patient-Developed Consent Forms Are Shorter, Better Understood
  • Jun 13, 2016
    Canadian Medical Groups Endorse Consensus Framework for Ethical Collaboration
  • Jun 13, 2016
    Companies Should Provide Public Disclosure Schedules When Seeking EU Market Authorization
  • Jun 3, 2016
    S.C. Governor Signs ‘Right-to-Try’ Bill
  • More

FDA Regulation & Enforcement

  • Feb 25, 2019
    Senate Finance Leaders Question Insulin Price Increases
  • Feb 25, 2019
    Senator Questions FDA on Opioid Marketing
  • Feb 20, 2019
    Shipments of Unsolicited Drugs by Compounding Pharmacy in Florida Lead to False Claims Act Settlement
  • Feb 20, 2019
    AMS Proposes To Add, Reclassify Substances on National Organic List
  • Feb 20, 2019
    Draft Guidance Shows How To Request Nonbinding FDA Feedback Following a Device Establishment Inspection
  • Feb 16, 2019
    Oregon Bill Would Require Wholesale Price Disclosure in Drug Ads
  • Feb 16, 2019
    Whistleblower Takes Gilead To Court Over Its FOCUS Program
  • Feb 15, 2019
    Study Finds Industry Payments To Cancer Physicians Over Time Increase Prescribing Rates
  • Feb 14, 2019
    FDA Finalizes Guidance on Public Warnings, Notifications Following Recalls of Violative Products
  • Feb 14, 2019
    FDA Begins Efforts To ‘Modernize’ Dietary Supplement Oversight
  • More

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