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Advertising & Promotion

  • 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
  • Oct 3, 2025
    OPDP Issues Untitled Letter Over Major Statement Presentation
  • Sep 26, 2025
    FDA DTC Promotion Crackdown Continues With Seven Warning Letters
  • Sep 19, 2025
    CDER Posts 40 DTC Advertising Untitled Letters
  • Sep 15, 2025
    CBER Issues First Promotional Untitled Letter Since 2018
  • Sep 10, 2025
    FDA Moves To Crack Down on Misleading Drug Ads
  • Sep 5, 2025
    Appeals Court Upholds Dismissal of Whistleblower Retaliation Case
  • Sep 3, 2025
    Appeals Court Upholds Dismissal of Lawsuit Over Promotional Slogan
  • More

Good Clinical Practice

  • 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
  • Oct 3, 2025
    FDA Issues Six Draft Guidances for Specific Disease Trials
  • Sep 26, 2025
    FDA Regs' Harmonization with Revised Common Rule Expected Soon
  • Sep 12, 2025
    Clinical Investigators Receive FDA Warning Letters Over Protocol Adherence
  • Sep 3, 2025
    UK To Launch Pilot Program To Speed Approval of Trial Changes
  • Aug 26, 2025
    AAMC Finds NIH Research Grants Down by Nearly $5 Billion
  • More

U.S. Food Labeling

  • 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
  • Aug 15,2025
    USDA Survey Examines Competing and Complementary Claims on Milk, Yogurt Product Packaging
  • 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

FDA Regulation & Enforcement

  • Nov 12, 2025
    Jury Finds for Novo Nordisk on False Claims Allegations Linked to Off-Label Marketing, Kickbacks
  • Nov 11, 2025
    New York Assembly Considers Gift Disclosure Bill
  • Nov 7, 2025
    Appeals Court Remands USDA GMO Disclosure Regs
  • Nov 6, 2025
    Janssen Challenges ‘Astronomical’ $1.64 Billion False Claims Judgment as Unconstitutional
  • Nov 3, 2025
    Group Offers Non-UPF Certification Program
  • Oct 29, 2025
    CEO Avoids Prison Time for Misbranding Conviction Linked to Devices’ Blood Lead Level Reading Errors
  • Oct 27, 2025
    Other Trump Administration Goals May Hamper DTC Enforcement
  • Oct 22, 2025
    CDRH Expands Early Alert Program for High-Risk Product Recalls To Include All Device Types
  • Oct 22, 2025
    Court: FD&C Act Does Not Prevent State Requirement That Supplements With Kratom Warn of Addiction
  • Oct 17, 2025
    CDER Posts Another 11 Untitled Letters
  • More

Medical Devices

  • Nov 12, 2025
    Revised Guidance on Pre-Requests for Designation Updates Process for Obtaining Agency Feedback
  • Nov 5, 2025
    Draft Guidance Details cGMP Info To Include in PMAs, HDEs Under New Quality Management System Reg
  • Oct 29, 2025
    CEO Avoids Prison Time for Misbranding Conviction Linked to Devices’ Blood Lead Level Reading Errors
  • Oct 29, 2025
    FDA Warns of Possible ‘Serious Complications’ Resulting From Use of RF Microneedling Devices
  • Oct 22, 2025
    CDRH Expands Early Alert Program for High-Risk Product Recalls To Include All Device Types
  • Oct 15, 2025
    Trade Groups See Inconsistencies Between Regs and Draft Guidance on UDIs for Combination Products
  • Oct 8, 2025
    CDRH Sets Guidance Development Priorities for FY 2026, Reports Progress Toward Guidance Finalization
  • Oct 2, 2025
    FDA Seeks Input From Public on How To Evaluate Real-World Performance of AI-Enabled Medical Devices
  • Oct 1, 2025
    Device Firm, Distributor Settle Claims That They Misrepresented Medicare Coverage Status of Tests
  • Sep 25, 2025
    Court Dismisses Purchasers’ Claims Against Device Firm Alleged To Have Misled FDA During PMA Process
  • More

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