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Advertising & Promotion

  • 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
  • Apr 3, 2024
    Former Device Execs Ask Supreme Court To Review Their Convictions for Alleged Off-Label Marketing
  • Mar 27, 2024
    Court Dismisses Kickback Case Against Allergan, Allows Plaintiffs To Amend Complaint
  • Mar 18, 2024
    CVM Issues Warning Letter Over Alleged Claims Made for New Animal Drug
  • Mar 5, 2024
    NJ Appeals Court Dismisses Cases Alleging Unlawful Marketing
  • Feb 20, 2024
    Drug Manufacturer To Pay $750,000 To Resolve Allegations of Paying Indirect Kickbacks to Doctor
  • Feb 19, 2024
    Senators Want FDA Action on Social Media Drug Promotions
  • Feb 9, 2024
    Bill To Ban Advertisement of Drugs Directly to the Public Introduced in Kentucky House
  • More

Good Clinical Practice

  • 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
  • Jun 7, 2024
    FDA Provides Best Practices for Responding to BIMO Inspection 483s
  • May 29, 2024
    HHS OIG Finds NIH Has ‘Limited Success’ With Expanding Trial Inclusion
  • May 10, 2024
    Controlled Drug Theft Leads to Investigator Warning Letter
  • May 3, 2024
    OMB Adds MENA to Race and Ethnicity Reporting Categories
  • Apr 26, 2024
    FDA Issues Cancer Trial Guidance on Lab Values, Performance Status, Washout Periods and Concomitant Medications
  • More

U.S. Food Labeling

  • 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
  • Jan 17,2024
    GAO Calls for More FDA Oversight of Dietary Supplements
  • Jan 11,2024
    FDA Holds Off on Calculating %DV of Nontraditional Sugars
  • Dec 27,2023
    Fischer Reintroduces Real MEAT Act in Senate
  • More

FDA Regulation & Enforcement

  • Jun 6, 2025
    Study Finds Increased Consumer Use of Nutrition Facts Labels
  • Jun 4, 2025
    Consent Decree Allows Evaluation of Company’s Claims That Products Are Devices, Not Unapproved Drugs
  • May 30, 2025
    Senator Questions FDA’s Commitment to DTC Oversight
  • May 30, 2025
    Pa. Legislature Considers Food Labeling Bills
  • May 26, 2025
    Physicians Ask Supreme Court To Review Decision Allowing FDA To Regulate Stem Cell Procedure
  • May 23, 2025
    OPDP Issues First Warning Letter in Nearly Two Years
  • May 21, 2025
    Device Firm CEO Pleads Guilty to Charge of Making False Statements to CMS Regarding Alleged Kickbacks
  • May 21, 2025
    DOJ Revises Criminal Enforcement Policies To Encourage Self-Disclosure of Corporate Wrongdoing
  • May 20, 2025
    Concerns Over Risk Claims Prompt Untitled Letter for Speaker Deck
  • May 14, 2025
    FDA, HHS Launch Deregulation Initiative, Seek Public Input on Outdated, Unneeded Rules, Guidance
  • More

Medical Devices

  • Nov 25, 2024
    Trump Names Dr. Marty Makary To Lead FDA
  • Nov 20, 2024
    Citing Preemption and Ohio Tort Law, Court Dismisses Claims Related to Cervical Disk Device Failure
  • Nov 13, 2024
    Associations File Amicus Briefs in Suit Challenging FDA Final Rule on Laboratory Developed Tests
  • Nov 6, 2024
    Medtronic Enters Into Settlement With Health Center That Alleged Bias in Pulse Oximeter Inaccuracies
  • Oct 30, 2024
    Marketer of Face Masks Misrepresented as N95s, Two Executives Plead Guilty to Misbranding Charges
  • Oct 30, 2024
    Court: Claims Related to a Contraceptive Device Are Barred by Statute of Limitations and Preempted
  • Oct 23, 2024
    CDRH Posts Trial Participation Snapshots To Report Device Benefits, Risks Among Patient Populations
  • Oct 16, 2024
    Cybersecurity, LDT Enforcement Discretion Are Priorities for CDRH Guidance Development in FY 2025
  • Oct 9, 2024
    Study: Underreporting of Sociodemographic Data for AI-Enabled Devices Boosts Risk of Algorithmic Bias
  • Oct 2, 2024
    FDA Updates 35-Year-Old Guidance on Electronic Product Radiation Control Regs for X-Ray Equipment
  • More

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