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Advertising & Promotion

  • 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
  • Mar 17, 2025
    CVM Issues First Advertising Enforcement 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
  • More

Good Clinical Practice

  • 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
  • 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
  • More

U.S. Food Labeling

  • 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
  • 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    FDA Provides Draft Guidance on Labeling Plant-Based Alternative Foods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
  • More

FDA Regulation & Enforcement

  • Dec 23, 2025
    GAO: HHS Should Work With FDA To Boost Oversight, Speed Resolutions of Medical Device Recalls
  • Dec 19, 2025
    FDA Considers DSHEA Disclaimer Change for Dietary Supplements
  • Dec 17, 2025
    FDA Calls for More Urgent Action on Recalls After Recalled Infant Formula Remained on Store Shelves
  • Dec 15, 2025
    FDA Posts One More Untitled Letter From September DTC Ad Blitz
  • Dec 12, 2025
    FSIS Updates Label Approval Guideline for US Origin Claims
  • Dec 10, 2025
    Court Upholds Conspiracy Conviction of Sales Executive Linked to Veterinarian Kickback Scheme
  • Dec 10, 2025
    FDA Final Guidance on Promotion of Biosimilars Adds Comparison Considerations
  • Dec 4, 2025
    OPDP Sends Untitled Letter for DTC Testimonial Video
  • Dec 2, 2025
    Supplement Firm, CEO Found Guilty on Charges Related to Fabricated cGMP Compliance Documents
  • Nov 26, 2025
    Formula Importer Is the First To Plead Guilty to Felony Charge of Violating Prior Notice Requirements
  • More

Medical Devices

  • Aug 13, 2025
    Device Firm Passes Muster With OIG Despite Agency’s Ongoing Suspicion of Physician-Owned Entities
  • Aug 6, 2025
    Device User Fee Increases Ease for FY 2026; FDA Will Consider Requests for Establishment Fee Waivers
  • Jul 31, 2025
    Illumina $9.8M False Claims Settlement Resolves Charge That Genome Devices Had Cyber Vulnerabilities
  • Jul 30, 2025
    FDA’s Regulatory Accelerator Offers Quick Access to Guidance, Tools for Digital Device Sponsors
  • 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
  • More

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