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Advertising & Promotion

  • Aug 28, 2025
    Ninth Circuit Upholds Oregon Law Requiring Disclosure of Cost, Price Info About Prescription Drugs
  • Aug 13, 2025
    Texas Accuses Lilly of Incentivizing Providers With Illegal Kickbacks Offered Through Two Programs
  • 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
  • Jun 28, 2025
    Xlear Sues FTC Over Substantiation of Marketing Claims
  • Jun 25, 2025
    Amazon Must Face Suit Alleging That It Marketed Dietary Supplements Without FDA-Required Disclaimers
  • Jun 20, 2025
    Congress Introduces Bills To Ban DTC Drug Ads
  • Jun 14, 2025
    OPDP Warning Letter Alleges Instagram Post Lacked Risk Info
  • May 30, 2025
    Senator Questions FDA’s Commitment to DTC Oversight
  • May 23, 2025
    OPDP Issues First Warning Letter in Nearly Two Years
  • More

Good Clinical Practice

  • Aug 21, 2025
    FDA Issues Two Draft Oncology Trial Guidances Focusing on Survival Assessments and Radiopharmaceutical Dosage
  • Aug 11, 2025
    DOD Expands TRICARE Clinical Trial Coverage
  • Aug 7, 2025
    NIH Revises Inclusion Policy To Reflect Executive Order
  • Jul 25, 2025
    FDA Pushes Selective Safety Data Collection
  • Jul 11, 2025
    Warning Letter Alleges Investigator Overdosed Two Pediatric Subjects
  • Jul 6, 2025
    Bill Exempting Trial Payments From Taxes Introduced in House
  • Jun 28, 2025
    Changes Coming for Federal Oversight of Human Research Protections
  • Jun 13, 2025
    Draft ICH Guideline Calls for Paradigm Shift in Enrolling Pregnant and Lactating Women in Clinical Trials
  • Jun 6, 2025
    CBER Issues First 2025 Warning Letter Addressing Clinical Trial Concerns
  • May 25, 2025
    CDRH Sends Sponsor Warning Letter Over Significant Risk Study Concerns
  • More

U.S. Food Labeling

  • Jul 25,2025
    Agencies Release RFI on Definition of Ultra-Processed Food
  • Jul 18,2025
    FDA Again Encourages Manufacturers To End Use of FD&C Red No. 3
  • Jul 11,2025
    FDA Issues Educational Material To Boost Understanding of NDIN Process
  • Jul 5,2025
    FDA Updates Staff Instructions on Food Labeling Requirements
  • Jun 25,2025
    Amazon Must Face Suit Alleging That It Marketed Dietary Supplements Without FDA-Required Disclaimers
  • Jun 25,2025
    Texas To Require Warning Labels for Foods Containing Artificial Colors, Additives
  • Jun 6,2025
    Study Finds Increased Consumer Use of Nutrition Facts Labels
  • May 30,2025
    Pa. Legislature Considers Food Labeling Bills
  • May 14,2025
    FDA, HHS Launch Deregulation Initiative, Seek Public Input on Outdated, Unneeded Rules, Guidance
  • May 9,2025
    FDA Extends Proposed FOP Rule Comment Period to July 15
  • More

FDA Regulation & Enforcement

  • Oct 15, 2025
    Ohio Court: State Cannot Enforce FDA Premarket Requirements Using State Consumer Protection Law
  • Oct 12, 2025
    EU Parliament Approves Stricter Definition of Meat
  • Oct 8, 2025
    DOJ Seeks Rulings in Regeneron Litigation Over Contributions to Foundation To Cover Medicare Copays
  • Oct 3, 2025
    OPDP Issues Untitled Letter Over Major Statement Presentation
  • Oct 1, 2025
    Device Firm, Distributor Settle Claims That They Misrepresented Medicare Coverage Status of Tests
  • Sep 26, 2025
    FDA DTC Promotion Crackdown Continues With Seven Warning Letters
  • Sep 25, 2025
    Court Dismisses Purchasers’ Claims Against Device Firm Alleged To Have Misled FDA During PMA Process
  • Sep 24, 2025
    FDA: Use of Alternate Assessment Tools Can Speed Agency’s Decisions on Drug, Biologic Applications
  • Sep 21, 2025
    Comment Period for RFI on Ultra-Processed Foods Extended to Oct. 23
  • Sep 19, 2025
    CDER Posts 40 DTC Advertising Untitled Letters
  • More

Medical Devices

  • Sep 18, 2025
    Exactech Enters Into $8 Million Resolution of Allegations Regarding Defective Knee Implants
  • Sep 10, 2025
    AdvaMed: Device Firms’ Use of Independent Sales Agents Does Not Violate Anti-Kickback Statute
  • Sep 3, 2025
    Kimberly-Clark To Pay Up to $40.4M for Selling Modified Surgical Gowns Without New 510(k) Clearance
  • Aug 27, 2025
    AdvaMed, Other Stakeholders Call for Streamlined Pathway to Medicare Coverage for Innovative Medtech
  • 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 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
  • More

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