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Advertising & Promotion

  • Sep 15, 2023
    GAO Finds Few Studies, Conflicting Opinions on DTC Device Ads
  • Sep 1, 2023
    OPDP Issues Untitled Letter About Sponsored Social Media Post
  • Aug 18, 2023
    OPDP Issues First Warning Letter in Over a Year
  • Aug 12, 2023
    Judge Enters Order of No Damages in False Ad Case
  • Aug 9, 2023
    Neuro Device Manufacturer, CEO Resolve False Claims Allegations Over Medicare Billing Codes
  • Aug 7, 2023
    New Zealand Tightens Direct-to-Consumer Advertising Law
  • Jul 31, 2023
    Supplement Company Settles Allegations of False Advertising
  • Jul 20, 2023
    Review Finds Discrepancies Between Clearance Documentation and Marketing for Some ‘Smart’ Devices
  • Jul 12, 2023
    Diagnostics Firm Penalized by SEC for Allegedly Misleading Press Releases About a COVID-19 Test
  • Jul 10, 2023
    FTC Sets Policy on Endorsements
  • More

Good Clinical Practice

  • Jan 2, 2024
    Conducting Assessments Without Proper Blinding Nets Investigator Warning Letter
  • Dec 22, 2023
    FDA Final Guidance Adds Recommendations on DHT Info Needed in Submissions
  • Dec 21, 2023
    FDA Harmonizes Informed Consent Waiver and Alteration Regs With Common Rule
  • Dec 3, 2023
    Miami Clinic Owner, Employee Sentenced in Clinical Trial Fraud Case
  • Nov 30, 2023
    OHRP Finds Complaints Against UCLA Study Were Unproven
  • Nov 21, 2023
    Investigator Is Issued Warning Letter Over Randomization Concerns
  • Nov 10, 2023
    FDA To Continue Remote BIMO Inspections
  • Nov 6, 2023
    FDA Warning Letter Cites Investigator Over Subject Eligibility and Case Histories
  • Oct 27, 2023
    NIH Requests Information on Consent Requirements for Using Digital Health Tech in Research
  • Oct 25, 2023
    FDA Outlines How It Conducts Remote Interactive Evaluations of Drug and Bioresearch Facilities
  • More

U.S. Food Labeling

  • May 31,2023
    FDA, USDA Sued Over Nutrient Content Claims
  • May 10,2023
    Food Label Modernization Bills Introduced in House and Senate
  • May 1,2023
    FDA Mulls Online Grocery Labeling
  • Apr 20,2023
    FDA Cites Firm for Recalled Products’ Labeling
  • Apr 5,2023
    FDA Releases Draft Guidance on Using Dietary Guidance Statements on Labels
  • Mar 23,2023
    FDA Stands Firm on Not Allowing CBD as Dietary Supplement
  • Mar 23,2023
    Second Cell Cultured Food Is Given Safety Greenlight
  • Mar 23,2023
    FDA Allows Cocoa Flavanol Qualified Health Claim
  • Mar 10,2023
    USDA Proposes To Regulate ‘Made in USA’ Label Claim To Better Align With Consumer Perceptions
  • Mar 2,2023
    Draft Guidance Allows Use of ‘Milk,’ Recommends Nutrition Information on Plant-Based Product Labeling
  • More

FDA Regulation & Enforcement

  • Jul 16, 2025
    HHS OIG: Device Maker’s Plan To Access Vendor’s Purchasing Portal Raises Kickback Concerns
  • Jul 16, 2025
    Court: Patient- and Provider-Support Programs for Humira Did Not Violate Anti-Kickback Statute
  • Jul 11, 2025
    FDA Issues Educational Material To Boost Understanding of NDIN Process
  • Jul 9, 2025
    DOJ-HHS Working Group Sets Priorities for False Claims Act Enforcement Targeting Health Care Fraud
  • 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
  • More

Medical Devices

  • Aug 28, 2024
    Molecular Pathology Association Asks Court To Vacate FDA’s Final Rule on Laboratory Developed Tests
  • Aug 21, 2024
    FDA Proposes Recommendations for Presenting Predetermined Change Control Plans in Device Submissions
  • Aug 14, 2024
    Industry Associations Express Disappointment With Medicare Coverage Pathway for Breakthrough Devices
  • Aug 7, 2024
    FDA Calls for Feedback on Clinical Trial Design, Agency Review To Assure Health Equity for Devices
  • Jul 31, 2024
    District Court: State Law Tort Claims Involving Class II De Novo Device Are Expressly Preempted
  • Jul 31, 2024
    FDA Bumps Up Device User Fees for FY 2025; No Waiver of Establishment Fees for Small Businesses
  • Jul 24, 2024
    FDA Responds to Stakeholder Questions About Complying With the Agency’s Final Rule on LDTs
  • Jul 17, 2024
    Revised Combination Product User Fee Guidance Outlines Available PDUFA, MDUFA Fee Waivers, Exceptions
  • Jul 10, 2024
    CDRH To Expand Total Product Life Cycle Program, Adding Radiological, Ophthalmic, Orthopedic Devices
  • Jul 3, 2024
    House Panel OKs Bill To Provide Four Years of Temporary Medicare Coverage for Breakthrough Devices
  • More

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