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Advertising & Promotion

  • Oct 4, 2022
    OPDP Researchers Plan To Move Forward With Study on Targeted Mechanism of Action Claims
  • Sep 28, 2022
    Biogen Settles False Claims Allegations for $900 Million; Relator To Receive Nearly $250 Million
  • Sep 25, 2022
    OPDP Researchers Plan Two New Studies
  • Sep 18, 2022
    District Court Dismisses Novartis Speaker Program Suit
  • Sep 14, 2022
    Third Circuit Upholds Dismissal of Lanham Act Case
  • Sep 7, 2022
    Bayer Settles Lawsuits Over Allegations of Kickbacks and False Statements
  • Aug 29, 2022
    Court Allows Federal FCA Case Against Abbott to Proceed
  • Aug 24, 2022
    Optical Lens Maker To Pay $22 Million To Resolve False Claims Liability Tied to Alleged Kickbacks
  • Aug 22, 2022
    Study Finds DTC Heart Drug Ads Have Little Effect on Lifestyle Intentions
  • Aug 14, 2022
    Risk Info in CSL Communications Aids Consumer Recognition, Study Finds
  • More

Good Clinical Practice

  • Dec 8, 2022
    ICH Final Guidance Recommends Uses for Selective Safety Data Collection
  • Nov 30, 2022
    Sponsor-Investigator Issued Warning Letter Over Failure To Submit IND for Combination Product
  • Nov 16, 2022
    FDA Extends Comment Period for Common Rule Harmonization Regulations by One Month
  • Nov 4, 2022
    FDA Details How Sponsors Should Make Expanded Access Policies Public and Available
  • Oct 28, 2022
    FDA Goes Beyond ICH Advice on Dealing with Multiple Endpoints in Clinical Trials
  • Oct 22, 2022
    SACHRP Counsels FDA on Common Rule Harmonization
  • Oct 14, 2022
    Owners of Another Miami Clinical Site Charged with Data Fabrication
  • Oct 11, 2022
    FDA Details Ethical Considerations for Pediatric Trials
  • Oct 2, 2022
    FDA Proposes Regulations To Harmonize with Revised Common Rule
  • Sep 23, 2022
    OHRP Issues Two Determination Letters
  • More

U.S. Food Labeling

  • Dec 9,2021
    FDA Is Asking for Input on Use of NAC as Dietary Supplement
  • Nov 21,2021
    Meeting Archive Available on Toxic Elements in Baby Food
  • Nov 21,2021
    Recordings From Food E-Commerce Summit Available
  • Nov 21,2021
    FSIS Extends Comment Period on Labeling Cell Cultured Meat, Poultry
  • Nov 18,2021
    Biden Nominates Dr. Robert Califf To Head the FDA Again as Commissioner of Food and Drugs
  • Nov 10,2021
    FDA Revises Temporary Marketing Permit Guidance To Streamline Process
  • Oct 28,2021
    Supplement Firm Enjoined From Selling Violative Products
  • Oct 14,2021
    FDA Publishes Guidance Setting Voluntary Sodium Reduction Targets for Food
  • Sep 30,2021
    FSIS Revises Guideline on Food Products Packaged as Kits
  • Sep 15,2021
    FSIS Asks for Comments on Cell Cultured Meat, Poultry Labeling
  • More

FDA Regulation & Enforcement

  • Mar 4, 2025
    Fig Bar Label Case Continues Over Use of ‘Wholesome’
  • Mar 1, 2025
    Senators Reintroduce Bill That Would Regulate Influencers’ Drug Posts
  • Feb 26, 2025
    Court Dismisses Failure-To-Warn Claim in Wrongful Death Suit Brought Against Drug Manufacturer
  • Feb 24, 2025
    FDA Pushes ‘Healthy’ Claim Final Rule Effective Date to April
  • Feb 21, 2025
    HFP Head Resigns Over ‘Indiscriminate’ Staff Layoffs
  • Feb 19, 2025
    First Circuit Sets High Bar for Establishing False Claims Violations Tied to Kickback Violations
  • Feb 12, 2025
    State Unfair Practices Claim Targeting Prescription Pet Food Is Preempted, District Court Rules
  • Feb 12, 2025
    Senators Ask FDA To Review Compounder’s Super Bowl Ad
  • Feb 7, 2025
    FDA Ponders SOI for High-Protein Yogurt
  • Feb 5, 2025
    Appeals Court Upholds Dismissal of Challenge to HHS OIG Advisory Opinion on Coalition Model PAP
  • More

Medical Devices

  • 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
  • Oct 25, 2023
    FDA Extends Policy Allowing Some Changes to Remote Monitoring Devices Without New 510(k) Submissions
  • Oct 17, 2023
    Additional Guidance on AI/Machine Learning Devices Included in FY 2024 Guidance Development Plan
  • Oct 16, 2023
    Former CEO Pleads Guilty to Marketing Migraine Treatment Device Without FDA’s Authorization
  • Oct 11, 2023
    FDA ‘Unsatisfied’ With Recall of Philips Respironics Devices; Senator Calls for Enforcement Action
  • Oct 1, 2023
    FDA Proposed Rule Would Fully Regulate LDTs as Devices With Phaseout of Enforcement Discretion
  • Sep 27, 2023
    Finalized Cybersecurity Guidance Covers FDORA Mandates, Adds Quality System and TPLC Recommendations
  • More

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