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Advertising & Promotion

  • Nov 14, 2018
    New Jersey Sues Janssen Over Opioid Marketing
  • Nov 13, 2018
    Appeals Court Finds Homeopathic Company’s Claims Were Not Misleading or Deceptive
  • Nov 12, 2018
    American Society for Aesthetic Plastic Surgery Add Industry Partnerships
  • Nov 2, 2018
    Australia Posts Changes to Advertising Code
  • Nov 1, 2018
    OPDP Cites Web Page for Lack of Risk Information
  • Oct 30, 2018
    ERSP Recommends Changes in Claims in Online Ads for Vitamin Vaporizer
  • Oct 29, 2018
    Abbott To Pay $25 Million To Resolve Kickback and Off-label Marketing Case
  • Oct 29, 2018
    McCaskill Releases Report on Insys Sales Strategy
  • Oct 26, 2018
    Kentucky Files Lawsuit Against Teva Over Off-label Promotion of Fentanyl-based Drugs
  • Oct 25, 2018
    FTC Settles Stem Cell Ad Case
  • More

Good Clinical Practice

  • Jan 24, 2019
    EMA Issues Third Revision of Guideline on Bacterial Infection Medicine Trials
  • Jan 24, 2019
    N.Y. Assembly Bill Looks To Change State Human Research Protection Rules
  • Jan 19, 2019
    HHS Issues Draft Guidance on Transitioning Studies to Revised Common Rule Requirements
  • Jan 18, 2019
    FDA Updates Draft Guidance on Rare Disease Drug Development
  • Jan 17, 2019
    Bills Introduced in N.Y. To Set Up Clinical Trial Access and Education Fund
  • Jan 17, 2019
    Texas Bill Looks to Extend Right-to-Try to Chronic Diseases
  • Jan 17, 2019
    Arizona Bill Would Allow Access to Investigational Stem Cell Treatments
  • Jan 16, 2019
    Australia Plans GCP Inspection Pilot
  • Jan 16, 2019
    Survey Finds Comorbidities Reduce Cancer Trial Discussions, Offers and Participation
  • Jan 14, 2019
    Sales Income Return Much Higher Than Research Costs for Cancer Drugs
  • More

U.S. Food Labeling

  • Apr 20,2015
    Warning Letter Finds Many Flaws with Kind’s Labeling of Snack Bars
  • Apr 20,2015
    Organic-focused Groups Sue USDA Over 2013 Changes to National Organics Program
  • Apr 14,2015
    Trade Groups: Vermont’s Latest Argument in GMO Labeling Case is Legal Non Sequitur
  • Apr 8,2015
    State AGs Ask Congress To Crack Down on Deceptive Supplement Labeling, Ads
  • Mar 25,2015
    Senate Bill Pushes Disclosure Label for Foods Packaged in BPA
  • Mar 24,2015
    Maine Legislators Look To Remove Limits on 2013 GMO Labeling Law
  • Mar 19,2015
    Celiac Patient Sues FDA Over Gluten in Drugs, Lack of Label Disclosure
  • Mar 14,2015
    Two States Introduce Pro-GMO Measures
  • Mar 13,2015
    FSIS Labeling Directive Pushes Verification Checks for Allergens
  • Mar 12,2015
    Compliance Guide Provides Simple Explanation of Menu Labeling Rules Ahead of Roll-out
  • More

FDA Regulation & Enforcement

  • Mar 9, 2022
    Sackler Family Settles with Eight States, D.C. Over Opioid Marketing
  • Mar 4, 2022
    District Court Rejects Claims That Food Products’ Labeling of Protein Content Was Misleading
  • Mar 3, 2022
    OPDP Researchers Detail Studies Planned in 2022
  • Mar 3, 2022
    FDA Plans Rulemaking Addressing State Policing of Drug Compounding, Extends Enforcement Discretion
  • Mar 2, 2022
    Qui Tam Suit Targeting Medtronic Proctorships, Other Business Practices Survives Motion To Dismiss
  • Feb 23, 2022
    Alabama Man Pleads Guilty to Charge of Marketing Misbranded SARMs, Defrauding FDA, Consumers
  • Feb 23, 2022
    OPDP Issues First 2022 Warning Letter Over Video Promoting Investigational New Drug
  • Feb 17, 2022
    Seven Senators Urge DOJ to Investigate Sacklers
  • Feb 17, 2022
    FTC Distributes Refunds to Supplement Purchasers
  • Feb 16, 2022
    Draft Guidance Offers Recommendations on How To Request Portions of Official Samples Taken by FDA
  • More

Medical Devices

  • Dec 28, 2017
    Voluntary Program for Streamlined Medical Device Reporting in Summary Form Launched by FDA
  • Dec 21, 2017
    Draft Guidance Calls for Applying ‘Least Burdensome’ Principles Throughout Device’s Total Product Life Cycle
  • Dec 15, 2017
    Medtronic Settles With Five States for $12 Million Over Infuse Marketing
  • Dec 13, 2017
    CDRH Finds Success with EFS Program
  • Dec 12, 2017
    FDA Continues Reform of Digital Health Device Regulation Through Guidance Documents, Public Workshop
  • Dec 4, 2017
    Final Guidance Modifies FDA Criteria Used To Categorize IDE Devices for CMS Coverage Determinations
  • Dec 3, 2017
    FDA’s ‘Streamlined’ Pathway to Market for Consumer Genetic Health Risk Tests Offers 510(k) Exemptions
  • Nov 30, 2017
    CDRH Issues Draft Guidance to Aid Study Designs for In Vitro Diagnostic Device Dual Submissions
  • Nov 28, 2017
    Final Guidance Offers Recommendations on Pediatric Information To Include in X-ray Imaging Device 510(k)s
  • Nov 20, 2017
    Final Version of Direct Marking Guidance Explains UDI Requirements for Multiuse, Reprocessed Devices
  • More

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