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Advertising & Promotion

  • 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
  • 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
  • More

Good Clinical Practice

  • 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
  • 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
  • More

U.S. Food Labeling

  • 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’
  • 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
  • More

FDA Regulation & Enforcement

  • Apr 16, 2025
    Study Finds Meat-like Names for Plant-based Products Could Confuse Consumers
  • Apr 16, 2025
    Fifth Circuit: Maker of FDA-Approved Drug May Sue Compounder Under State Unfair Competition Statutes
  • Apr 15, 2025
    Vanda Pharmaceuticals Challenges Constitutionality of FDA's Restrictions on Off-Label Marketing
  • Apr 9, 2025
    Firm To Pay $550K To Resolve False Claims Allegations Linked to Multiple Uses of Single-Use Devices
  • Apr 4, 2025
    OPDP Flags Efficacy Webpage With Untitled Letter
  • Apr 2, 2025
    Diopsys Inc. To Pay Up to $14.25 Million To Resolve False Claims Allegations Involving Vision Testing
  • Mar 28, 2025
    FDA Answers Questions on Food Allergen Labeling
  • Mar 27, 2025
    Senate Votes To Confirm Makary as FDA Commissioner
  • Mar 26, 2025
    Study: Nearly a Third of Device Manufacturer Adverse Event Reports Do Not Meet Regulatory Deadlines
  • Mar 26, 2025
    Former Magellan CEO Joins Other Execs in Pleading Guilty to Charge Related to Faulty Blood Lead Tests
  • More

Medical 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
  • Jun 26, 2024
    CDRH Initiative Seeks To Reimagine the Home as Part of Health Care System To Advance Health Equity
  • Jun 19, 2024
    CEO Who Marketed Neurostimulation Device With Nonfunctioning Component Receives Six-Year Sentence
  • Jun 18, 2024
    AMA Calls for More Women and SGMs in Clinical Trials
  • Jun 12, 2024
    Clinical Lab Association, Member Company Sue To Block FDA’s Final Rule on LDTs
  • More

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