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Advertising & Promotion

  • Jan 16, 2026
    OPDP Issues Untitled Letters for Branded Backgrounds, Webpages and DTC TV Ad
  • Dec 27, 2025
    OPDP Contends Clinical Trial Results Don’t Support Cobenfy DTC TV Ad Claims
  • Dec 15, 2025
    FDA Posts One More Untitled Letter From September DTC Ad Blitz
  • Dec 10, 2025
    FDA Final Guidance on Promotion of Biosimilars Adds Comparison Considerations
  • Dec 4, 2025
    OPDP Sends Untitled Letter for DTC Testimonial Video
  • Nov 21, 2025
    Study Finds Influencers’ Drug Social Media Posts Lack Risk Info and Disclosures
  • Nov 19, 2025
    OPDP Posts Three Untitled Letters
  • Nov 11, 2025
    New York Assembly Considers Gift Disclosure Bill
  • Oct 27, 2025
    Other Trump Administration Goals May Hamper DTC Enforcement
  • Oct 17, 2025
    CDER Posts Another 11 Untitled Letters
  • More

Good Clinical Practice

  • Dec 23, 2025
    Newly Finalized Guidance Offers Insights on BIMO Inspections Not Provided in Agency Guides, Manuals
  • Dec 19, 2025
    FDA Revises Guidances on Safety Reporting
  • Dec 10, 2025
    First NACHRP Guidance To Focus on IRB Flexibility for Minimal Risk Research
  • Dec 3, 2025
    IFPMA Proposes Regulatory Reliance for Multiregional Trial Review
  • Nov 19, 2025
    Sponsor-Investigator Receives Warning Letter After Allegedly Failing To Submit IND for Trial
  • Nov 5, 2025
    Reagan-Udall Foundation Roundtable Develops Recommendations for Oncology MRCTs
  • Oct 24, 2025
    Final Guidance Details Waiting Period, IRB Requirements for Expanded Access
  • Oct 17, 2025
    National Academies Report Recommends Ways To Simplify Research Regulations
  • Oct 10, 2025
    WHO Launches Global Forum on Clinical Trials
  • Oct 5, 2025
    Sponsor-Investigator Receives Warning Letter After Allegedly Failing To Submit IND for Trial
  • More

U.S. Food Labeling

  • Dec 19,2025
    FDA Considers DSHEA Disclaimer Change for Dietary Supplements
  • Dec 12,2025
    FSIS Updates Label Approval Guideline for US Origin Claims
  • Nov 26,2025
    Researchers Examine Effect of Calorie Information in FOP Labels
  • Nov 7,2025
    Appeals Court Remands USDA GMO Disclosure Regs
  • Nov 3,2025
    Group Offers Non-UPF Certification Program
  • Oct 22,2025
    Court: FD&C Act Does Not Prevent State Requirement That Supplements With Kratom Warn of Addiction
  • Oct 12,2025
    EU Parliament Approves Stricter Definition of Meat
  • Sep 21,2025
    Comment Period for RFI on Ultra-Processed Foods Extended to Oct. 23
  • Sep 9,2025
    FOPL Final Rule Expected in May 2026
  • Aug 26,2025
    CRS Report Provides Options for Congress on Food Labeling
  • More

FDA Regulation & Enforcement

  • Mar 5, 2026
    Preemption, Inadequate Pleading Doom Patient’s Tort Suit Against Pain Management Device Manufacturer
  • Mar 4, 2026
    Court Won’t Halt Suit Alleging Amazon Supplement Labeling Violations While FDA Ponders Reg Change
  • Feb 27, 2026
    Clinical Investigator Receives Warning Letter Over Incorrect Dosing
  • Feb 27, 2026
    CVM Issues First Promotion Warning Letter of 2026
  • Feb 25, 2026
    Device Maker’s Non-Prosecution Agreement Resolves Allegations of Health Care, Securities Fraud
  • Feb 25, 2026
    District Court Issues Injunction Against Texas Warning Label Law
  • Feb 20, 2026
    Florida Bills Would Allow Individuals To Sue Over Vaccine Harm, If Products Are Advertised in the State
  • Feb 18, 2026
    OIG Offers Anti-Kickback Guidelines for Direct-to-Consumer Drug Sales Through Programs Like TrumpRx
  • Feb 13, 2026
    FDA Will Allow ‘No Artificial Colors’ Labels for Products Not Using Oil-Based Dyes
  • Feb 13, 2026
    OPDP Sends Five Untitled Letters Over DTC TV Ads
  • More

Medical Devices

  • Jan 28, 2026
    HHS OIG Gives Green Light to Proposed Waiver of Co-Payments for Colorectal Cancer Screening Test
  • Jan 21, 2026
    Legislation Would Streamline Device Recalls With Electronic Reporting, Mandate Patient Notifications
  • Jan 20, 2026
    Trade Groups Tell FDA To Use Current Regulatory Tools To Monitor Performance of AI-Enabled Devices
  • Jan 14, 2026
    Court: Some Claims Against PMA Device Maker Linked to Alleged Off-Label Promotion Survive Preemption
  • Jan 14, 2026
    Tennessee Physician Found Guilty on Device Adulteration, Misbranding and Health Care Fraud Charges
  • Jan 7, 2026
    FDA Exempts Broad Categories of Low Risk General Wellness Products From Scrutiny as Devices
  • Dec 23, 2025
    Newly Finalized Guidance Offers Insights on BIMO Inspections Not Provided in Agency Guides, Manuals
  • Dec 23, 2025
    GAO: HHS Should Work With FDA To Boost Oversight, Speed Resolutions of Medical Device Recalls
  • Dec 17, 2025
    FDA Allows Use of Real-World Evidence Without Including Identifiable Individual Patient Information
  • Dec 10, 2025
    Digital Device Firms May Obtain Enforcement Discretion for Some FDA Mandates Under Pilot Program
  • More

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