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Advertising & Promotion

  • Oct 21, 2024
    JAMA Article Reports Half of Top Journals’ Peer Reviewers Received Industry Payments
  • Oct 15, 2024
    Teva $450M Payment Resolves Kickback, False Claims Allegations Linked to Patient Co-Pays, Price Fixing
  • Oct 11, 2024
    OPDP Researchers To Examine Talk Show Drug Promotion; Move Ahead with Adherence and Preference Claims Study
  • Sep 27, 2024
    AI Company Reaches Agreement with Texas Over Marketing Claims
  • Sep 20, 2024
    Industry Concerned Draft Guidance on Responding to Misinformation Is Too Narrow and Raises First Amendment Issues
  • Sep 15, 2024
    AbbVie Receives Untitled Letter Over Ubrelvy TV Ad
  • Aug 23, 2024
    FTC Approves Final Rule on Product Reviews and Testimonials
  • Aug 13, 2024
    Court: Claims Challenging Marketing of Tylenol Rapid Release Gelcaps Are Expressly Preempted
  • Aug 12, 2024
    OPDP Plans To Survey HCPs About Bad Ad Program and Other Issues
  • Aug 2, 2024
    OPDP Issues Two Untitled Letters
  • More

Good Clinical Practice

  • Oct 25, 2024
    WMA Revises Declaration of Helsinki
  • Oct 23, 2024
    CDRH Posts Trial Participation Snapshots To Report Device Benefits, Risks Among Patient Populations
  • Oct 18, 2024
    Researcher Debarred for Three Years Over Alleged Research Misconduct
  • Oct 15, 2024
    Louisiana Research Center Receives FDA Warning Letter over IRB Operational Concerns
  • Oct 9, 2024
    Study: Underreporting of Sociodemographic Data for AI-Enabled Devices Boosts Risk of Algorithmic Bias
  • Oct 7, 2024
    New OHRP Director Named
  • Sep 27, 2024
    WHO Releases Final Clinical Trial Guidance
  • Sep 20, 2024
    HHS Updates 20-Year-Old Research Integrity Regulations
  • Sep 17, 2024
    FDA Provides Guidance on DCT Elements, Multiregional Trials and Integrating Randomized Trials into Clinical Practice
  • Sep 5, 2024
    Clinical Investigator Receives Warning Letter Over Subject Dosing
  • More

U.S. Food Labeling

  • Aug 16,2024
    Appeals Court Rejects Challenge to USDA’s Decision on Poultry Labeling
  • Aug 9,2024
    FSANZ Consumer Survey Finds More Trust in Back-of-Package Labeling
  • Jul 19,2024
    Group Offers ‘Seed Oil Free Certified’ Seal
  • Jul 13,2024
    District Court Finds ‘Manufactured in the USA’ Label False
  • Jul 5,2024
    Appeals Court Sends Baby Food Nutrient Statement Case Back to Trial Court
  • Jun 28,2024
    Bakery Gets Warning Letter for Allegedly Including Allergens Among Ingredients When Allergens Are Not in the Product
  • Jun 12,2024
    Court Dismisses Suit Alleging Bottled Water Labeling Was Deceptive Due to Presence of Microplastics
  • Jun 11,2024
    Consumer Survey Finds No Clear Winner Among FOP Label Schemes
  • May 30,2024
    Court Allows Class Action Suit Against Pasta Maker Over Labeling
  • May 11,2024
    Bakeries Issued Warning Letters Alleging Labeling Violations
  • More

FDA Regulation & Enforcement

  • Oct 27, 2025
    Other Trump Administration Goals May Hamper DTC Enforcement
  • Oct 22, 2025
    CDRH Expands Early Alert Program for High-Risk Product Recalls To Include All Device Types
  • Oct 22, 2025
    Court: FD&C Act Does Not Prevent State Requirement That Supplements With Kratom Warn of Addiction
  • Oct 17, 2025
    CDER Posts Another 11 Untitled Letters
  • Oct 15, 2025
    Ohio Court: State Cannot Enforce FDA Premarket Requirements Using State Consumer Protection Law
  • Oct 12, 2025
    EU Parliament Approves Stricter Definition of Meat
  • Oct 8, 2025
    DOJ Seeks Rulings in Regeneron Litigation Over Contributions to Foundation To Cover Medicare Copays
  • Oct 3, 2025
    OPDP Issues Untitled Letter Over Major Statement Presentation
  • Oct 1, 2025
    Device Firm, Distributor Settle Claims That They Misrepresented Medicare Coverage Status of Tests
  • Sep 26, 2025
    FDA DTC Promotion Crackdown Continues With Seven Warning Letters
  • More

Medical Devices

  • Apr 16, 2025
    Senators Introduce Bill To Establish Medicare Payment Pathway for AI-Enabled Medical Devices
  • Apr 9, 2025
    Firm To Pay $550K To Resolve False Claims Allegations Linked to Multiple Uses of Single-Use Devices
  • Apr 2, 2025
    Diopsys Inc. To Pay Up to $14.25 Million To Resolve False Claims Allegations Involving Vision Testing
  • Apr 1, 2025
    District Court: FDA Final Rule Regulating Laboratory Developed Tests as Medical Devices Is Unlawful
  • Mar 27, 2025
    Senate Votes To Confirm Makary as FDA Commissioner
  • Mar 26, 2025
    Study: Nearly a Third of Device Manufacturer Adverse Event Reports Do Not Meet Regulatory Deadlines
  • Mar 26, 2025
    Former Magellan CEO Joins Other Execs in Pleading Guilty to Charge Related to Faulty Blood Lead Tests
  • Mar 19, 2025
    AdvaMed Urges Court Not To Allow Claims Where Future Injury From Ethylene Oxide Is Merely Possible
  • Mar 12, 2025
    FDA Will Reject All Study Data From Device Testing Firm in China Due to Data Integrity Concerns
  • Mar 5, 2025
    Two Former Magellan Executives Enter Plea Agreements Related to Blood Lead Level Test Malfunctions
  • More

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