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Advertising & Promotion

  • 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
  • Apr 26, 2024
    FDA Issues Revised Guidance on Promotion of Biosimilars
  • Apr 23, 2024
    Endo Health Solutions Pleads Guilty to Marketing Opioid as Abuse Deterrent Without Supporting Data
  • Apr 5, 2024
    Industry Paid U.S. Physicians $12 Billion During First Decade of Mandatory Reporting
  • More

Good Clinical Practice

  • 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    AMA Releases Draft Guidance on Reporting Demographic Information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’
  • Jul 19, 2024
    FDA Remote Regulatory Assessment Results in Warning Letter for MIT IRB
  • Jul 7, 2024
    Determination Letter Alleges IRB Approved Research Without Sufficient Information
  • Jul 1, 2024
    FDA Provides Format and Content Recommendations for Trial Diversity Action Plans
  • Jun 26, 2024
    Warning Letter Alleges Sponsor-Investigator Did Not Follow All Expanded Access Requirements
  • Jun 18, 2024
    AMA Calls for More Women and SGMs in Clinical Trials
  • More

U.S. Food Labeling

  • 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
  • Mar 20,2024
    FDA Revokes Standards of Identity and Quality for Frozen Cherry Pie
  • Mar 19,2024
    UK Starts Consultation on Food Labeling
  • Mar 14,2024
    FSIS Issues ‘Product of USA’ Label Claim Rule
  • Mar 5,2024
    FDA OKs Qualified Health Claims for Yogurt
  • Feb 29,2024
    New Zealand Revises Food Labeling Regs To Add Allergy Information
  • Feb 2,2024
    Bills Look To Rein In Labeling for Egg Alternatives
  • Jan 26,2024
    Flanders Adopts ‘Animal-Friendly’ Food Labels
  • More

FDA Regulation & Enforcement

  • 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
  • Sep 18, 2025
    Exactech Enters Into $8 Million Resolution of Allegations Regarding Defective Knee Implants
  • Sep 17, 2025
    Appeals Court Upholds False Claims Penalty of Over $183M for Lilly’s Medicaid Drug Price Reporting
  • Sep 15, 2025
    CBER Issues First Promotional Warning Letter Since 2016
  • Sep 11, 2025
    Brand-Name Drug Maker Must Face Suit Brought Following Death of Patient Who Took Generic Version
  • Sep 10, 2025
    AdvaMed: Device Firms’ Use of Independent Sales Agents Does Not Violate Anti-Kickback Statute
  • Sep 10, 2025
    FDA Moves To Crack Down on Misleading Drug Ads
  • More

Medical Devices

  • Mar 4, 2025
    AdvaMed’s Legislative Agenda Urges Quicker CMS Coverage Decisions, Policies That Keep Pace With AI
  • Mar 3, 2025
    Pathologists’ Association Calls for Trump Administration To Revoke Final FDA Rule on LDTs
  • Feb 26, 2025
    Much of FDA’s Fired Device Staff Is Reportedly Reinstated Following Industry, Congressional Pushback
  • Feb 12, 2025
    FDA Tells Diabetes Device Makers, Users That Critical Alerts From Mobile Apps Are Being Missed
  • 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
  • More

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