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Advertising & Promotion

  • Aug 1, 2022
    FTC Opens Endorsement and Testimonial Guide Revisions for Public Comment
  • Jul 29, 2022
    Device Maker Settles Kickback Allegations
  • Jul 25, 2022
    FDA Issues Warning Letter Over Compounded Drug Claims
  • Jul 15, 2022
    House Bill Would Set Deadline for FDA’s Final Rule on DTC Prescription Drug Ads
  • Jul 8, 2022
    FTC Consent Order Bans Two Companies and Owner from Advertising or Selling Dietary Supplements
  • Jul 1, 2022
    Release of FDA’s Final Rule on DTC Drug Ads Pushed to May 2023
  • Jun 27, 2022
    Oregon Issues Permanent Rules for Drug Sales Rep Licensing
  • Jun 20, 2022
    FTC Enforcement To Focus on PBM Rebates and Fees
  • Jun 10, 2022
    Washington Supreme Court: Direct-to-Consumer Advertising Does Not Dilute Learned Intermediary Doctrine
  • Jun 7, 2022
    Third OPDP Untitled Letter of 2022 Cites Risk Presentation, Efficacy Claims
  • More

Good Clinical Practice

  • Sep 18, 2022
    New Draft Guidance on Clinical Pharmacology Considerations for Pediatric Studies Expands 2014 Guidance
  • Sep 12, 2022
    Work Group Issues Recommendations To Improve Communication with Subjects When Trials End Early
  • Sep 6, 2022
    ORI Opens 'Brainstorming Process' for Research Misconduct Rule Revision
  • Aug 26, 2022
    FDA Provides Additional Answers on Charging for Investigational Drugs
  • Aug 19, 2022
    OIG Audit Finds NIH-funded Trials Not Posting Results
  • Aug 12, 2022
    SACHRP Asks for More Clarity in HHS Single IRB Guidance
  • Aug 1, 2022
    SACHRP Recommends New Definitions of ‘Engagement’ and ‘Support’
  • Jul 29, 2022
    Sponsor-investigator Receives FDA Warning Letter; BRANY Gets Determination Letter
  • Jul 24, 2022
    Two More Clinical Trial Staff Plead Guilty to Falsifying Data
  • Jul 20, 2022
    Abbott Funds Clinical Trial Diversity Program
  • More

U.S. Food Labeling

  • Sep 1,2021
    Congress Again Moves To Mandate Updates to Food Labeling
  • Aug 19,2021
    FDA Rejects NDIs for CBD Products Intended To Be Marketed as Dietary Supplements
  • Aug 4,2021
    Courts in Three Separate Product Actions Side With Trader Joe’s
  • Jul 22,2021
    FDA Releases Preview of Planned Upcoming Labeling Guidances
  • Jul 8,2021
    USDA Commits to Wholesale Review of ‘Product of USA’ Labeling
  • Jun 23,2021
    FDA Updates Standard of Identity for Yogurt Products
  • Jun 15,2021
    NOSB Will Meet in October
  • Jun 9,2021
    Supplement Firm Asks Court To Dismiss Class Action
  • May 26,2021
    AMS Releases Results of 2020 NOP Enforcement Activity
  • May 13,2021
    FDA Undertakes Research on ‘Healthy’ Symbols as Prelude to Regulations
  • More

FDA Regulation & Enforcement

  • Jan 31, 2025
    Sen. Sanders To Reintroduce Food Warning Label Legislation
  • Jan 29, 2025
    Pfizer To Pay Nearly $60 Million To Resolve Kickback Allegations Arising From Subsidiary’s Speaker Programs
  • Jan 29, 2025
    Court Dismisses False Claims Allegations Against IVD Device Maker, Citing Rule 9(b) Particularity
  • Jan 28, 2025
    Congress Reintroduces Bills To Require Price Disclosures in DTC Ads
  • Jan 24, 2025
    FDA Provides Draft Guidance on Labeling Plant-Based Alternative Foods
  • Jan 22, 2025
    Providing Free Drug That Has Only Limited Coverage Will Not Trigger Sanctions, HHS OIG Says
  • Jan 17, 2025
    FDA Proposes Front-of-Package Label for Food Products
  • Jan 15, 2025
    OIG: Patient Assistance for Autologous T-Cell Treatment Would Not Trigger Administrative Sanctions
  • Jan 15, 2025
    Former McKinsey Partner Pleads Guilty to Obstruction Charge Tied to Firm’s Advice to Purdue Pharma
  • Jan 10, 2025
    FDA Issues ‘Safe Harbor’ Guidance on Providing SIUU Info to Health Care Providers
  • More

Medical Devices

  • Sep 21, 2023
    FDA Finalizes Biocompatibility Recommendations for Devices Using Common Polymers, Natural Fabrics
  • Sep 15, 2023
    GAO Finds Few Studies, Conflicting Opinions on DTC Device Ads
  • Sep 14, 2023
    Breakthrough Designation Can Apply to Devices Addressing Health Inequities Under Updated Guidance
  • Sep 14, 2023
    DOJ Counters Device Maker’s Argument That False Claims Act Qui Tam Suits Violate U.S. Constitution
  • Sep 7, 2023
    FDA: Three New Draft 510(k) Guidance Documents Address Increased Complexity of Medical Devices
  • Aug 30, 2023
    Device Maker Calls for Dismissal of False Claims Act Suit, Saying Qui Tam Provisions Are Unconstitutional
  • Aug 24, 2023
    Court Dismisses Ohio Tort Law Claims Brought by Patient Injured by Migrations of Surgical Clips
  • Aug 17, 2023
    CDRH Officials Report Return to Normal Operations, Surge in Device Innovation Following COVID-19
  • Aug 9, 2023
    Neuro Device Manufacturer, CEO Resolve False Claims Allegations Over Medicare Billing Codes
  • Aug 3, 2023
    Increases Announced for Device User Fees in FY 2024
  • More

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