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Advertising & Promotion

  • Aug 13, 2024
    Court: Claims Challenging Marketing of Tylenol Rapid Release Gelcaps Are Expressly Preempted
  • Aug 12, 2024
    OPDP Plans To Survey HCPs About Bad Ad Program and Other Issues
  • Aug 2, 2024
    OPDP Issues Two Untitled Letters
  • Jul 26, 2024
    OPDP Research Finds Disease Awareness Ads Could Confuse Consumers on Drug Risks and Benefits
  • Jul 17, 2024
    Compounder Pleads Guilty, Former Sales Exec Indicted in Connection With Vet Drug Kickback Scheme
  • Jul 13, 2024
    FDA To Exercise Enforcement Discretion for ‘Tailored’ Responses to Internet Misinformation
  • Jun 27, 2024
    Kansas Sues Pfizer Over COVID-19 Vaccine Claims
  • Jun 14, 2024
    BMJ Article Details Mallinckrodt’s Medical Information Strategies for Opioids
  • Jun 2, 2024
    JAMA Analysis Examines Physician Product Endorsements on X
  • May 6, 2024
    Prominently Disclosing Study Rigor May Aid Promotional Claims
  • More

Good Clinical Practice

  • Oct 7, 2024
    New OHRP Director Named
  • Sep 27, 2024
    WHO Releases Final Clinical Trial Guidance
  • Sep 20, 2024
    HHS Updates 20-Year-Old Research Integrity Regulations
  • Sep 17, 2024
    FDA Provides Guidance on DCT Elements, Multiregional Trials and Integrating Randomized Trials into Clinical Practice
  • Sep 5, 2024
    Clinical Investigator Receives Warning Letter Over Subject Dosing
  • Aug 29, 2024
    AMA Releases Draft Guidance on Reporting Demographic Information
  • Aug 16, 2024
    Foreign BIMO Inspection Leads to Warning Letter
  • Aug 7, 2024
    FDA Calls for Feedback on Clinical Trial Design, Agency Review To Assure Health Equity for Devices
  • Aug 3, 2024
    SACHRP Makes Recommendations for Conduct of LGBTQI+ Research
  • Jul 26, 2024
    Article Contends Subject Compensation Reform ‘Badly Overdue’
  • More

U.S. Food Labeling

  • Jul 13,2024
    District Court Finds ‘Manufactured in the USA’ Label False
  • Jul 5,2024
    Appeals Court Sends Baby Food Nutrient Statement Case Back to Trial Court
  • Jun 28,2024
    Bakery Gets Warning Letter for Allegedly Including Allergens Among Ingredients When Allergens Are Not in the Product
  • Jun 12,2024
    Court Dismisses Suit Alleging Bottled Water Labeling Was Deceptive Due to Presence of Microplastics
  • Jun 11,2024
    Consumer Survey Finds No Clear Winner Among FOP Label Schemes
  • May 30,2024
    Court Allows Class Action Suit Against Pasta Maker Over Labeling
  • May 11,2024
    Bakeries Issued Warning Letters Alleging Labeling Violations
  • Apr 22,2024
    Bill To Require FOP Warning Labels Introduced in Senate
  • Apr 18,2024
    District Court Dismisses Labeling Case Against Dole Fruit Products
  • Mar 30,2024
    District Court Allows Case Over ‘Good for the Environment’ Label To Proceed
  • More

FDA Regulation & Enforcement

  • Jul 5, 2025
    FDA Updates Staff Instructions on Food Labeling Requirements
  • Jul 2, 2025
    Manufacturer Payments for Injury From Device Failure Come Within Warranty Safe Harbor, HHS OIG Says
  • 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 25, 2025
    Texas To Require Warning Labels for Foods Containing Artificial Colors, Additives
  • Jun 24, 2025
    OIG: Device Firm’s Payment for Customers’ Compliance Checks Would Violate Anti-Kickback Statute
  • Jun 20, 2025
    Congress Introduces Bills To Ban DTC Drug Ads
  • Jun 18, 2025
    DOJ Revises Policy on Foreign Corrupt Practices Act Enforcement, With a Focus on U.S. Interests
  • Jun 14, 2025
    OPDP Warning Letter Alleges Instagram Post Lacked Risk Info
  • Jun 11, 2025
    HHS OIG: FDA Must Address Gaps in Domestic Food Facility Inspections
  • More

Medical Devices

  • Feb 3, 2025
    FDA Warns of Cybersecurity Vulnerabilities in Patient Monitors Produced by China-Based Device Firm
  • Jan 29, 2025
    Court Dismisses False Claims Allegations Against IVD Device Maker, Citing Rule 9(b) Particularity
  • Jan 22, 2025
    CDRH Director Calls for Expanded Authority To Collect Information About Medical Device Shortages
  • Jan 15, 2025
    Updated Guidance Finalizes List of Devices Subject to Reporting Mandates Intended To Ease Shortages
  • Jan 8, 2025
    Draft Guidance Addresses Marketing Submissions, Total Product Life Cycle for AI-Enabled Devices
  • Jan 1, 2025
    FDA: FAQs Can Help Identify Regulatory Requirements Applicable to Clinical Decision Support Software
  • Dec 18, 2024
    Device Trade Associations Weigh In on FDA’s Guidance Development Priorities for Fiscal Year 2025
  • Dec 11, 2024
    CDRH Provides Early Alert of Potentially High-Risk Device Recall Under Pilot Program
  • Dec 4, 2024
    Final Guidance on PCCPs for AI-Enabled Software Expands Info on Labeling, Postmarket Surveillance
  • Nov 26, 2024
    Enforcement Discretion Policy Can Help Device Firms Facing Potential EtO Sterilization Restrictions
  • More

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