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Advertising & Promotion

  • May 21, 2025
    Device Firm CEO Pleads Guilty to Charge of Making False Statements to CMS Regarding Alleged Kickbacks
  • May 20, 2025
    Concerns Over Risk Claims Prompt Untitled Letter for Speaker Deck
  • May 14, 2025
    FDA, HHS Launch Deregulation Initiative, Seek Public Input on Outdated, Unneeded Rules, Guidance
  • May 14, 2025
    Assertio Therapeutics Enters Into $3.6M Settlement To Resolve Off-Label False Claims Allegations
  • May 9, 2025
    Gilead Agrees to $202 Million Settlement Over Speaker Program
  • May 5, 2025
    House-Senate Bills Look To End DTC Ad Tax Deduction
  • Apr 15, 2025
    Vanda Pharmaceuticals Challenges Constitutionality of FDA's Restrictions on Off-Label Marketing
  • Apr 4, 2025
    OPDP Flags Efficacy Webpage With Untitled Letter
  • Mar 27, 2025
    Senate Votes To Confirm Makary as FDA Commissioner
  • Mar 21, 2025
    State Legislatures Consider Bills That Would Ban DTC Ads
  • More

Good Clinical Practice

  • May 20, 2025
    OHRP Closes N.Y. Psychiatric Institute Investigation
  • May 14, 2025
    FDA, HHS Launch Deregulation Initiative, Seek Public Input on Outdated, Unneeded Rules, Guidance
  • May 7, 2025
    Investigator Receives Warning Letter for Allegedly Not Following Exclusion Criteria
  • Apr 25, 2025
    FDA Reiterates Interest in Advancing Digital Health Technologies in Trials
  • Apr 18, 2025
    UK Updates Clinical Trial Rules
  • Apr 4, 2025
    Revised FDA Device Guidance Removes Diversity References
  • Mar 28, 2025
    OHRP Investigations Clear Four Research Centers
  • Mar 27, 2025
    Senate Votes To Confirm Makary as FDA Commissioner
  • Mar 21, 2025
    FDA Sends Warning Letters to Two Clinical Investigators
  • Mar 14, 2025
    FDA Debars Research Center Owner
  • More

U.S. Food Labeling

  • Apr 25,2025
    FDA Moves To Remove All Petroleum-Based Dyes From Food
  • Apr 18,2025
    Menendez Reintroduces Caffeine Labeling Bill
  • Apr 16,2025
    Study Finds Meat-like Names for Plant-based Products Could Confuse Consumers
  • Mar 28,2025
    FDA Answers Questions on Food Allergen Labeling
  • Mar 27,2025
    Senate Votes To Confirm Makary as FDA Commissioner
  • Mar 4,2025
    Fig Bar Label Case Continues Over Use of ‘Wholesome’
  • Feb 24,2025
    FDA Pushes ‘Healthy’ Claim Final Rule Effective Date to April
  • Feb 21,2025
    HFP Head Resigns Over ‘Indiscriminate’ Staff Layoffs
  • Feb 7,2025
    FDA Ponders SOI for High-Protein Yogurt
  • Jan 31,2025
    Sen. Sanders To Reintroduce Food Warning Label Legislation
  • More

FDA Regulation & Enforcement

  • Sep 18, 2025
    Exactech Enters Into $8 Million Resolution of Allegations Regarding Defective Knee Implants
  • Sep 17, 2025
    Appeals Court Upholds False Claims Penalty of Over $183M for Lilly’s Medicaid Drug Price Reporting
  • Sep 15, 2025
    CBER Issues First Promotional Untitled Letter Since 2018
  • Sep 11, 2025
    Brand-Name Drug Maker Must Face Suit Brought Following Death of Patient Who Took Generic Version
  • Sep 10, 2025
    AdvaMed: Device Firms’ Use of Independent Sales Agents Does Not Violate Anti-Kickback Statute
  • Sep 10, 2025
    FDA Moves To Crack Down on Misleading Drug Ads
  • Sep 9, 2025
    FOPL Final Rule Expected in May 2026
  • Sep 5, 2025
    Appeals Court Upholds Dismissal of Whistleblower Retaliation Case
  • Sep 4, 2025
    DOJ: False Claims Qui Tam Suits Are Constitutional; Off-Label Marketing Alone Does Not Violate Statute
  • Sep 3, 2025
    Kimberly-Clark To Pay Up to $40.4M for Selling Modified Surgical Gowns Without New 510(k) Clearance
  • More

Medical Devices

  • Jul 23, 2025
    Trump Grants Two-Year EPA Rule Compliance Reprieve to Device Sterilization Facilities Using EtO
  • Jul 16, 2025
    HHS OIG: Device Maker’s Plan To Access Vendor’s Purchasing Portal Raises Kickback Concerns
  • Jul 9, 2025
    Draft Guidance Offers Recommendations for Complying With UDI Requirements for Combination Products
  • Jul 2, 2025
    FDA Finalizes Premarket Submission Recommendations for Medical Devices Vulnerable to Cyber Risks
  • Jul 2, 2025
    Manufacturer Payments for Injury From Device Failure Come Within Warranty Safe Harbor, HHS OIG Says
  • Jun 24, 2025
    OIG: Device Firm’s Payment for Customers’ Compliance Checks Would Violate Anti-Kickback Statute
  • Jun 18, 2025
    Claims Brought by Patient for Damages Related to IUD That Had Migrated to Her Abdomen Are Dismissed
  • Jun 11, 2025
    Under Proposed Legislation, Medicare, Medicaid Would Cover Prescription Digital Therapeutics
  • Jun 4, 2025
    Consent Decree Allows Evaluation of Company’s Claims That Products Are Devices, Not Unapproved Drugs
  • Jun 4, 2025
    FDA Outlines Pathways for Device Feedback in Finalized Guidance, Launches Pre-Sub eSTAR Submissions
  • More

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