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Advertising & Promotion

  • Dec 21, 2023
    OPDP Researchers To Examine Implied Claims in DTC Drug Promotion
  • Dec 21, 2023
    Court Upholds Convictions for Off-Label Promotion of Device, Rejecting First Amendment Arguments
  • Dec 13, 2023
    Citizen Petition Calls for FDA To Remove ‘Misleading’ Promotional Claims From Botox Labeling
  • Nov 20, 2023
    FDA Issues Final Rule on Major Statement in DTC Drug Ads
  • Nov 17, 2023
    FTC Sends Warning Letters Regarding Lack of Disclosure in Social Media Posts
  • Nov 13, 2023
    OPDP Issues Two Untitled Letters Alleging False or Misleading Claims in DTC Materials
  • Oct 31, 2023
    FDA Issues Revised Draft Guidance on Providing Scientific Information on Unapproved Uses
  • Oct 21, 2023
    Bill Requiring Price Disclosure in DTC Ads Introduced in House
  • Oct 18, 2023
    OPDP Researchers To Examine Adherence and Preference Claims
  • Oct 4, 2023
    Petitions Over Compliance Guidance and Notice of Penalty Offenses Filed With FTC
  • More

Good Clinical Practice

  • Mar 18, 2024
    CDRH Sends Warning Letter for Myriad of Alleged Trial Problems
  • Mar 11, 2024
    Joint FDA-OHRP Draft Guidance Details ‘Key Information’ in Informed Consent
  • Feb 28, 2024
    Final COVID-19 Guidance Provides More Options for Trial Sponsors
  • Feb 16, 2024
    New FDA Draft Guidance Focuses on When and How To Use Data Monitoring Committees
  • Feb 9, 2024
    New FDA Draft Guidance on Race and Ethnicity Data Collection Recommends Including Race and Ethnicity Information in Proposed Labeling
  • Jan 27, 2024
    OHRP Determination Letter Cites University for Allegedly Not Following Revised Common Rule
  • Jan 22, 2024
    Nonprofit Pays $19.5 Million Over Self-Reported FCA Claims
  • Jan 12, 2024
    CTTI, FDA Offer Ways To Improve Trial Registration and Reporting
  • Jan 10, 2024
    Clinical Investigator Receives Warning Letter Over Protocol and IRB Approval Lapse
  • Jan 4, 2024
    OIG: Subsidies for Study Participants Covered by Medicare Would Not Pose Undue Risk of Fraud, Abuse
  • More

U.S. Food Labeling

  • Sep 30,2023
    Citizen Petition Requests That Gluten Be Declared a Major Food Allergen
  • Sep 25,2023
    Bill To Study ‘Climate-Friendly’ Certification and Labeling Introduced in US House
  • Sep 20,2023
    Citing Implied Preemption, First Circuit Affirms Dismissal of Complaint Targeting Lactaid Label Claims
  • Sep 8,2023
    French Study Finds Two FOL Statements Can Be Independently Perceived and Understood
  • Aug 26,2023
    Appeals Court Affirms Dismissals of Complaints Over Cereal Protein Claims
  • Aug 15,2023
    Smokehouse Almond Labeling Cases Go Up in Smoke
  • Aug 3,2023
    California Dairy Enters Into Consent Decree To Resolve Allegations That It Marketed Raw Milk Products
  • Jul 21,2023
    Illinois To Push Voluntary Uniform Food Product Dating Terms
  • Jun 30,2023
    FDA Triples Number of Subjects for Proposed FOPL Survey
  • Jun 12,2023
    Literature Review Finds Interpretive FOPL Is ‘More Comprehensible and Equitable’
  • More

FDA Regulation & Enforcement

  • Aug 13, 2025
    Texas Accuses Lilly of Incentivizing Providers With Illegal Kickbacks Offered Through Two Programs
  • Aug 13, 2025
    Device Firm Passes Muster With OIG Despite Agency’s Ongoing Suspicion of Physician-Owned Entities
  • 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
  • Aug 6, 2025
    Court: FD&C Act’s Civil Money Penalty Provisions for Tobacco Products Violate Seventh Amendment
  • Jul 31, 2025
    Illumina $9.8M False Claims Settlement Resolves Charge That Genome Devices Had Cyber Vulnerabilities
  • Jul 25, 2025
    Agencies Release RFI on Definition of Ultra-Processed Food
  • 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
  • Jul 18, 2025
    FDA Again Encourages Manufacturers To End Use of FD&C Red No. 3
  • More

Medical Devices

  • 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
  • Sep 25, 2024
    With Pilot Program's End, FDA Provides Updated Guidance for Assessing Conformity to Consensus Standards
  • Sep 19, 2024
    Draft Guidance on Using Patient Preference Information Goes Beyond Premarket Submissions for Devices
  • Sep 11, 2024
    Final Malfunction Summary Reporting Guidance Clarifies Eligibility, Provides Form FDA 3500A Examples
  • Sep 11, 2024
    Device Maker To Pay $700K To Resolve Allegations of Encouraging Use of Incorrect Billing Codes
  • Aug 28, 2024
    DOJ Adds Conspiracy, Fraud Charges Against Biolab Operator Who Allegedly Sold Illegal COVID-19 Tests
  • Aug 28, 2024
    FDA: De Novo Electronic Submission Guidance Can Help Device Sponsors Prepare for October 2025 Mandate
  • More

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