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Advertising & Promotion

  • Dec 30, 2022
    FTC Expands Advertising Guide To Include All Health-Related Claims
  • Dec 23, 2022
    Florida Supreme Court Considers Grand Jury Investigation of Manufacturers’ COVID-19 Vaccine Claims
  • Dec 19, 2022
    FDA: Ads for Hypertension Drugs Should Cite Cardiovascular Outcome Claims
  • Dec 15, 2022
    PMCPA Finds Novo Nordisk Breached ABPI Code in Weight Management Course Sponsorship
  • Dec 1, 2022
    Teva and Allergan Agree to Nationwide Opioid Marketing Settlements
  • Nov 17, 2022
    FDA Allows Makers of Six COVID-19 Drugs To Provide Safety, Efficacy Results in Promotional Material
  • Nov 9, 2022
    Former Physician, Former Pharma Sales Rep Plead Guilty to Charges Related to Compounded Drug Scheme
  • Nov 6, 2022
    Study: More Than a Third of Physicians, APCs Receive Industry Payments
  • Nov 3, 2022
    Doctor, Avanir Sales Rep Plead Guilty to Fraud Conspiracy Charges Stemming from Kickback Scheme
  • Nov 1, 2022
    IFPMA and EFPIA Provide Advice on Use of Social Media
  • More

Good Clinical Practice

  • Mar 24, 2023
    FDA Extensively Revises Clinical Trial Electronic Records Guidance
  • Mar 17, 2023
    Sponsor-Investigator Receives Warning Letter for Failing to Submit an IND
  • Mar 13, 2023
    FDA BIMO Inspections Rebound in FY 2022
  • Mar 9, 2023
    FDA Provides Roadmap for Externally Controlled Trials
  • Mar 1, 2023
    Group Petitions FDA To Improve Enforcement of Trial Reporting Mandates
  • Feb 22, 2023
    GAO Recommends More Oversight of IRBs
  • Feb 10, 2023
    Former CRO Owner Debarred
  • Feb 3, 2023
    Community Hospital IRB Receives Warning Letter Over Membership Concerns
  • Jan 29, 2023
    FDA, NIH Asked To Explain Their Enforcement of Trial Reporting Requirements
  • Jan 23, 2023
    FDA Debars Former Testing Site Owner
  • More

U.S. Food Labeling

  • May 24,2022
    FDA Warns Companies About Selling Violative Supplements
  • May 12,2022
    Draft Guidances Released on NAC as Supplement, How FDA Will Evaluate Non-listed Food Allergens
  • Apr 18,2022
    Survey Finds ‘Organic’ Unclear to Consumers; Antibiotics Found in Cattle Labeled ‘RWA’
  • Apr 14,2022
    FDA Upholds Position That NAC Is Not a Supplement, Promises Enforcement Guidance
  • Mar 31,2022
    FDA Responds to Comments Received on ‘Healthy’ Symbol
  • Mar 17,2022
    Association Continues To Press FDA on Changes to Artificial Sweetener Labeling
  • Mar 4,2022
    District Court Rejects Claims That Food Products’ Labeling of Protein Content Was Misleading
  • Feb 17,2022
    FTC Distributes Refunds to Supplement Purchasers
  • Feb 15,2022
    Senate Narrowly Confirms Califf as FDA Commissioner
  • Feb 3,2022
    FSIS Plans ‘Product of USA’ Labeling Survey, Seeks Input
  • More

FDA Regulation & Enforcement

  • Jan 5, 2025
    Senators Want Payments to Advocacy Organizations Made Public
  • Jan 1, 2025
    Manufacturer and Its President Plead Guilty to FD&C Act Violations in Marketing of Adulterated Fruit Juice
  • Dec 21, 2024
    FDA’s Human Foods Program Sends Warning Letter Over Cookie Labeling
  • Dec 21, 2024
    FDA Updates ‘Healthy’ Claim, Says FOP Proposal Out Soon
  • Dec 18, 2024
    McKinsey To Pay $650 Million To Resolve Liability for Consulting Work Performed for Purdue Pharma
  • Dec 14, 2024
    Senate Hearing Focuses on FOP and Other Labeling Issues
  • Dec 11, 2024
    Biopharma, Clinical Research Executives Convicted on Charges Related to Scheme To Deceive Investors
  • Dec 11, 2024
    CDRH Provides Early Alert of Potentially High-Risk Device Recall Under Pilot Program
  • Dec 10, 2024
    Public Citizen Asks FTC To Examine Dr. Oz’s iHerb Social Media Posts
  • Dec 6, 2024
    FDA, FSIS Want Information on Food Date Labeling
  • More

Medical Devices

  • Dec 21, 2023
    Court Upholds Convictions for Off-Label Promotion of Device, Rejecting First Amendment Arguments
  • Dec 14, 2023
    FDA: Final Guidance Will Help Device Makers Comply With Reporting Mandates To Mitigate Shortages
  • Dec 13, 2023
    Device Firm Official Pleads Guilty to Securities Fraud, Obstruction Over COVID-19 Test Fraud Scheme
  • Dec 6, 2023
    FDA Reaches Device Electronic Submission Milestone by Making eSTAR Template Available for PMAs
  • Nov 30, 2023
    FDA Proposes New Classifications, PMA Requirements for Some Wound Dressings and Liquid Wound Washes
  • Nov 22, 2023
    Final Guidance on Computational Modeling, Simulation for Devices Clarifies Scope of Recommendations
  • Nov 15, 2023
    FDA, Health Canada, UK’s MHRA Set Guiding Principles for AI/ML-Enabled Device Change Control Plans
  • Nov 9, 2023
    State AGs: Race Bias in Functioning of Pulse Oximeters Is ‘Just One Piece’ of Discriminatory Medtech
  • Nov 2, 2023
    Extending COVID-19 Policy, FDA Says PMA, HDE Supplements Are Not Needed for Some Device Changes
  • Nov 2, 2023
    OIG: Offering Free Hearing Aid With Cochlear Implant Device Could Result in Anti-Kickback Sanctions
  • More

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