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Advertising & Promotion

  • Nov 25, 2024
    Trump Names Dr. Marty Makary To Lead FDA
  • Nov 15, 2024
    OPDP Issues Untitled Letter Over Instagram Post
  • Nov 1, 2024
    CBO Finds Eliminating or Limiting DTC Ads Would Result in Very Small Reductions in Drug Prices
  • 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    Industry Concerned Draft Guidance on Responding to Misinformation Is Too Narrow and Raises First Amendment Issues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
  • More

Good Clinical Practice

  • Nov 25, 2024
    Trump Names Dr. Marty Makary To Lead FDA
  • Nov 22, 2024
    FDA Debars Trial Center Owner and Employee
  • Nov 15, 2024
    National Academies Report Finds Use of Race and Ethnicity in Research Needs Reevaluation
  • Nov 12, 2024
    SACHRP Examines Equivalent Protections in Foreign Trials, Completes Work on Uninformative Research
  • Nov 5, 2024
    FDA Sends Warning Letters to Investigator, IRB
  • 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
  • More

U.S. Food Labeling

  • Nov 25,2024
    Trump Names Dr. Marty Makary To Lead FDA
  • Nov 9,2024
    FDA Looks To Update ‘Healthy’ Claim, Propose FOP Labeling in FY 2025
  • Oct 25,2024
    Senate HELP Committee To Examine FOP Labeling
  • Oct 8,2024
    California To Standardize Quality, Safety Date Wording on Food Labels in 2026
  • Sep 10,2024
    FSIS Updates Substantiation Guidance for Animal-Raising and Environmental Label Claims
  • Aug 27,2024
    FDA Promises FOPL NPRM in October, Final Rule on ‘Healthy’ Definition in September
  • Aug 23,2024
    FDA Moves to Phase II of Its Sodium Reduction Program
  • 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
  • More

FDA Regulation & Enforcement

  • Aug 6, 2025
    Court: FD&C Act’s Civil Money Penalty Provisions for Tobacco Products Violate Seventh Amendment
  • Jul 31, 2025
    Illumina $9.8M False Claims Settlement Resolves Charge That Genome Devices Had Cyber Vulnerabilities
  • Jul 25, 2025
    Agencies Release RFI on Definition of Ultra-Processed Food
  • Jul 23, 2025
    Janssen’s Appeal of $1.64B Off-Label Judgment Includes Constitutional Challenge to False Claims Act
  • Jul 18, 2025
    Data Limitation Disclosures Can Temper Conference Attendees' Perceptions of Promoted Drugs
  • Jul 18, 2025
    FDA Again Encourages Manufacturers To End Use of FD&C Red No. 3
  • Jul 16, 2025
    HHS OIG: Device Maker’s Plan To Access Vendor’s Purchasing Portal Raises Kickback Concerns
  • Jul 16, 2025
    Court: Patient- and Provider-Support Programs for Humira Did Not Violate Anti-Kickback Statute
  • Jul 11, 2025
    FDA Issues Educational Material To Boost Understanding of NDIN Process
  • Jul 9, 2025
    DOJ-HHS Working Group Sets Priorities for False Claims Act Enforcement Targeting Health Care Fraud
  • More

Medical Devices

  • 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
  • Mar 4, 2025
    AdvaMed’s Legislative Agenda Urges Quicker CMS Coverage Decisions, Policies That Keep Pace With AI
  • Mar 3, 2025
    Pathologists’ Association Calls for Trump Administration To Revoke Final FDA Rule on LDTs
  • Feb 26, 2025
    Much of FDA’s Fired Device Staff Is Reportedly Reinstated Following Industry, Congressional Pushback
  • Feb 12, 2025
    FDA Tells Diabetes Device Makers, Users That Critical Alerts From Mobile Apps Are Being Missed
  • More

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