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Advertising & Promotion

  • Dec 5, 2013
    FDA Modifies Views on Intended Use of ‘Research Use Only,’ ‘Investigational Use Only’ IVD Devices
  • Dec 3, 2013
    Provision in Compounding Act Restores Limited FDA Oversight of Compounders' Promotions
  • Dec 3, 2013
    Drug Quality and Security Act Boosts Regulation of Compounders, Clarifies FDA Oversight Authority
  • Nov 23, 2013
    OPDP Issues Warning Letter Over Hep. C Notice, Two Untitled Letters Over Promotions to Doctors
  • Nov 19, 2013
    FDA Updates Guidance on Naming Conventions, Eases Expectations for Use of Established Name
  • Nov 18, 2013
    Speaker: Unsupported Health Claims At Risk of Drawing Class Action Suits
  • Nov 14, 2013
    Drug Maker Hit With OPDP Untitled Letter Over Website’s Efficacy Claims, Omissions
  • Nov 12, 2013
    OPDP Fires Off Warning Letter Over TV Interview; Untitled Letter Over Claims in Direct Mailing
  • Nov 10, 2013
    Johnson & Johnson To Pay $2.2 Billion, Plead Guilty To in Off-label Promotion Settlement
  • Nov 10, 2013
    FTC Sues hCG Marketer Over Weight-loss Claims
  • More

Good Clinical Practice

  • Jan 26, 2016
    Senators Ask NIH About Implementation of National Pediatric Research Network
  • Jan 25, 2016
    ‘Right-to-Try’ Bill Introduced in Nebraska
  • Jan 23, 2016
    CDER Plans To Release Number of Clinical Trial Related Draft Guidances in 2016
  • Jan 23, 2016
    FDA Examines Biotrial Phase 1 Study
  • Jan 23, 2016
    ‘Right-to-Try’ Bill Introduced in Rhode Island
  • Jan 23, 2016
    Companion Maryland ‘Right-to-Try’ Bills Introduced; Three N.Y. Bills Referred
  • Jan 22, 2016
    Tennessee Bills Mandate Insurance Coverage for Hypofractionated Proton Therapy Trials
  • Jan 21, 2016
    ICMJE Wants Deidentified Patient Data Sharing
  • Jan 20, 2016
    Public Citizen Asks VA To Investigate Trial Conduct at Three Centers
  • Jan 8, 2016
    FTC Provides Recommendations on Use of Big Data
  • More

FDA Regulation & Enforcement

  • Oct 26, 2018
    Kentucky Files Lawsuit Against Teva Over Off-label Promotion of Fentanyl-based Drugs
  • Oct 25, 2018
    Supplements Were Subject of Many Recent NAD Decisions
  • Oct 25, 2018
    FTC Settles Stem Cell Ad Case
  • Oct 25, 2018
    District Court Temporarily Halts Company Advertising in FTC Dispute
  • Oct 24, 2018
    TINA.org Files FTC Compliant Over Cancer Center Marketing Testimonials
  • Oct 24, 2018
    Former Compounder of Medical Creams Settles False Claims Act Allegations Following Self-Disclosure
  • Oct 22, 2018
    FDA Examines Disclosures in DTC Promotional Materials for Accelerated Approval Products
  • Oct 22, 2018
    OPDP Researchers To Examine Physician Perception of Drug Communications
  • Oct 22, 2018
    PhRMA Volunteers Adding Pricing Link to DTC TV Ads
  • Oct 22, 2018
    CMS Proposes Pricing Statement Rule for DTC TV Ads
  • More

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