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Advertising & Promotion

  • Mar 17, 2025
    CVM Issues First Advertising Warning Letters of 2025
  • Mar 12, 2025
    Court Grants Summary Judgment to Allergan on Kickback-Based False Claims, Off-Label Allegations
  • Mar 7, 2025
    Alleged Lack of Risk Info on Exhibit Panel Nets Untitled Letter
  • Mar 1, 2025
    Senators Reintroduce Bill That Would Regulate Influencers’ Drug Posts
  • Feb 12, 2025
    Senators Ask FDA To Review Compounder’s Super Bowl Ad
  • Jan 28, 2025
    Congress Reintroduces Bills To Require Price Disclosures in DTC Ads
  • Jan 10, 2025
    FDA Issues ‘Safe Harbor’ Guidance on Providing SIUU Info to Health Care Providers
  • Jan 5, 2025
    Senators Want Payments to Advocacy Organizations Made Public
  • Dec 18, 2024
    McKinsey To Pay $650 Million To Resolve Liability for Consulting Work Performed for Purdue Pharma
  • Dec 10, 2024
    Public Citizen Asks FTC To Examine Dr. Oz’s iHerb Social Media Posts
  • More

Good Clinical Practice

  • Mar 13, 2025
    Trial Site Owners Plead Guilty to Conspiracy To Commit Wire Fraud
  • Feb 21, 2025
    Multisite Research Companies Launch Trade Association
  • Feb 14, 2025
    FDA Issues Warning Letter to Sponsor for Allegedly Not Submitting IND Before Starting Clinical Trials
  • Feb 7, 2025
    Responsible AI Oversight Needed in Clinical Research: ACRP
  • Jan 31, 2025
    FDA Sends Investigator Warning Letter Over Informed Consent
  • Jan 17, 2025
    FDA Provides Guidance for Five Clinical Trial Issues
  • Jan 8, 2025
    Athira To Pay Over $4 Million To Resolve False Claims Allegations Stemming From Research Misconduct
  • Dec 29, 2024
    FDA Draft Guidance Defines ‘Important’ Protocol Deviations and Provides Recommendations for Handling Them
  • Dec 14, 2024
    FDA Details Confirmatory Trials for Accelerated Approval Drugs
  • Dec 5, 2024
    Sponsor, Investigator Receive BIMO Warning Letters
  • More

U.S. Food Labeling

  • Jan 24,2025
    FDA Provides Draft Guidance on Labeling Plant-Based Alternative Foods
  • Jan 17,2025
    FDA Proposes Front-of-Package Label for Food Products
  • Jan 10,2025
    FDA Allergen Labeling Guidance Expands Interpretation of 'Milk,' 'Eggs'
  • Jan 5,2025
    FDA Sets Jan. 1, 2028, as Next Uniform Compliance Date for New Labeling Regs
  • Dec 21,2024
    FDA’s Human Foods Program Sends Warning Letter Over Cookie Labeling
  • Dec 21,2024
    FDA Updates ‘Healthy’ Claim, Says FOP Proposal Out Soon
  • Dec 14,2024
    Senate Hearing Focuses on FOP and Other Labeling Issues
  • Dec 6,2024
    FDA, FSIS Want Information on Food Date Labeling
  • Nov 29,2024
    FSIS Sets Jan. 1, 2028, as Next Uniform Compliance Date for New Labeling Regs
  • Nov 27,2024
    Appeals Court Upholds Dismissal of Complaint Alleging Fruit Cup Labeling Was False
  • More

FDA Regulation & Enforcement

  • Sep 3, 2025
    Appeals Court Upholds Dismissal of Lawsuit Over Promotional Slogan
  • Aug 28, 2025
    Ninth Circuit Upholds Oregon Law Requiring Disclosure of Cost, Price Info About Prescription Drugs
  • Aug 26, 2025
    CRS Report Provides Options for Congress on Food Labeling
  • Aug 21, 2025
    SpineFrontier CEO Dodges Prison Term on False Statements Charge Related to Alleged Kickback Scheme
  • Aug 20, 2025
    Citing Preemption, Court Rejects Claims Brought Against Defibrillator Maker Following Patient Death
  • Aug 15, 2025
    USDA Survey Examines Competing and Complementary Claims on Milk, Yogurt Product Packaging
  • Aug 13, 2025
    Texas Accuses Lilly of Incentivizing Providers With Illegal Kickbacks Offered Through Two Programs
  • Aug 13, 2025
    Device Firm Passes Muster With OIG Despite Agency’s Ongoing Suspicion of Physician-Owned Entities
  • Aug 10, 2025
    Bill To Standardize Food Date Labels Introduced in Senate
  • Aug 7, 2025
    Proposed Front-of-Package Labeling Rule Produces Over 13,000 Comments
  • More

Medical Devices

  • May 26, 2025
    FDA Bans Use of Device Study Data From a Second Chinese Testing Facility in Premarket Submissions
  • May 21, 2025
    Device Firm CEO Pleads Guilty to Charge of Making False Statements to CMS Regarding Alleged Kickbacks
  • May 14, 2025
    FDA, HHS Launch Deregulation Initiative, Seek Public Input on Outdated, Unneeded Rules, Guidance
  • May 7, 2025
    FDA Is Sued Along With Boston Scientific Over Allegedly Faulty Spinal Cord Stimulator Device
  • Apr 30, 2025
    State Law Claims Brought by Survivors of Victim of Faulty ICD Dismissed on Preemption Grounds
  • Apr 23, 2025
    AdvaMed Urges Congress, Federal Agencies To Ensure Patient Access to AI-Enabled 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
  • More

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