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Advertising & Promotion

  • Dec 5, 2019
    GSK Sues BI Over Inhaler Marketing Claims
  • Nov 27, 2019
    Outcome Health Executives and Employees Charged in Connection with Advertising Scam
  • Nov 27, 2019
    Federal Court in Boston Overturns Some Verdicts Against Four Insys Therapeutics Executives
  • Nov 27, 2019
    OPDP Issues Seventh Untitled Letter for 2019
  • Nov 22, 2019
    Major Statement Rule Pushed Back Again
  • Nov 22, 2019
    Co-Pay Fund To Pay $4 Million To Settle Kickback Charges
  • Nov 22, 2019
    W.Va. Files Suit Against Two Opioid Makers
  • Nov 20, 2019
    Group Urges FDA-FTC Warning Letters Over Fertility Supplement Marketing
  • Nov 19, 2019
    Study Finds Disclosures Don’t Change Physician Perception of Off-label Information
  • Nov 18, 2019
    OPDP Sends Untitled Letter Over Promotion of Investigational Drug
  • More

Good Clinical Practice

  • Nov 25, 2019
    FDA Details How Sponsors Can Obtain Discretionary Certificates of Confidentiality for Non-Federal Studies
  • Nov 25, 2019
    Public Citizen Asks FDA To Investigate Company Partnership with Louisiana Prisons
  • Nov 23, 2019
    OHRP Excepts Two Types of Research From Revised Common Rule Mandate for Single IRB Review
  • Nov 22, 2019
    HHS Plans To Make Rules Dealing With Vulnerable Populations Compatible with Revised Common Rule
  • Nov 22, 2019
    EMA Releases Guidelines for Gout Studies
  • Nov 21, 2019
    Senators Question Large Commercial IRBs Over Potential Conflicts of Interest
  • Nov 19, 2019
    Strengthened Systematic Trial Reporting Needed
  • Nov 16, 2019
    Guidance on Smallpox Drug Development Examines Healthy Volunteer Safety and Emergency Trials
  • Nov 13, 2019
    IMDRF Releases Guidance on Device Clinical Trials
  • Nov 13, 2019
    Biotech Company Sues FDA, Saying Clinical Hold Provision Is Unconstitutional
  • More

U.S. Food Labeling

  • Feb 14,2018
    House Passes 'Common Sense' Menu Labeling Bill
  • Feb 8,2018
    Agencies Agree to Cooperate on GMO, Other Oversight
  • Jan 31,2018
    Agencies Warn Firms about 'Baseless' Product Claims
  • Jan 24,2018
    FDA Decides Against Claim Linking Vitamin D, Reduced Risk of MS
  • Jan 17,2018
    USDA Organic Standards Board Schedules April Meeting
  • Jan 17,2018
    FDA Extends Comment Period on Soy Protein, CHD Health Claim
  • Jan 11,2018
    Court Dismisses ‘Organic’ Lawsuit, Holding Claim Is Preempted
  • Jan 11,2018
    Suit Claiming Starbucks Underfills Lattes Is Dismissed
  • Jan 3,2018
    Report Examines Strengths, Weaknesses of Food Label Standards
  • Dec 27,2017
    FDA Disbands Food Advisory Committee After 25 Years
  • More

FDA Regulation & Enforcement

  • Aug 30, 2023
    Device Maker Calls for Dismissal of False Claims Act Suit, Saying Qui Tam Provisions Are Unconstitutional
  • Aug 26, 2023
    Appeals Court Affirms Dismissals of Complaints Over Cereal Protein Claims
  • Aug 24, 2023
    Court Dismisses Ohio Tort Law Claims Brought by Patient Injured by Migrations of Surgical Clips
  • Aug 23, 2023
    FDA Orders Second Permanent Debarment Linked to Multimillion-Dollar Sunscreen Testing Fraud
  • Aug 18, 2023
    OPDP Issues First Warning Letter in Over a Year
  • Aug 16, 2023
    House Commerce Committee Leadership Grills FDA on Foreign Inspections, Reliance on Imported Drugs
  • Aug 15, 2023
    Smokehouse Almond Labeling Cases Go Up in Smoke
  • Aug 12, 2023
    Judge Enters Order of No Damages in False Ad Case
  • Aug 9, 2023
    Court: Generic Drug Maker Had No State Law Duty To Give Warnings Not Provided for Brand-Name Drug
  • Aug 9, 2023
    Neuro Device Manufacturer, CEO Resolve False Claims Allegations Over Medicare Billing Codes
  • More

Medical Devices

  • Nov 25, 2020
    Final Guidance on Microneedling Devices Reflects Class II Classification for Aesthetic Use Products
  • Nov 19, 2020
    Draft Guidance Details Electromagnetic Compatibility Data To Provide to FDA in Device Submissions
  • Nov 11, 2020
    Kentucky Supreme Court Reverses Preemption-Based Ruling Against Plaintiffs Involving Catheter with IDE
  • Nov 8, 2020
    Medtronic Agrees To Pay $9.2 Million To Settle FCA Case
  • Nov 2, 2020
    FDA Lists Essential Devices, Other Medical Products To Stockpile for Future Public Health Emergencies
  • Oct 27, 2020
    CDRH Calls for Comments on Best Ways To Communicate Info About Device Cybersecurity Vulnerabilities
  • Oct 22, 2020
    CDRH Posts Guidance Development Goals for FY 2021
  • Oct 15, 2020
    Former Compliance Officer’s Qui Tam Suit Leads to $18 Million Settlement with Merit Medical Systems
  • Oct 15, 2020
    FDA Proposes Alternatives to Submitting Biocompatibility Data for Devices Using Common Polymers, Fabrics
  • Oct 3, 2020
    FDA Finalizes Guidance on Use of ISO 10993-1 in Evaluation of Biocompatibility of Medical Devices
  • More

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