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Advertising & Promotion

  • May 12, 2020
    J&J Reaches $3.9 Million Settlement with West Virginia over Marketing of Surgical Mesh Products, Hip Replacement Devices
  • May 12, 2020
    Court Imposes Order of Permanent Injunction on Hand Sanitizer Manufacturer That Defied FDA Mandates
  • May 5, 2020
    N.Y. Goes After Mallinckrodt for Alleged Insurance Fraud Related to Opioid Marketing
  • Apr 28, 2020
    Los Angeles Reaches Agreements with Two Companies Over Marketing of COVID-19 Kits
  • Apr 20, 2020
    Court Issues Temporary Restraining Order Against Florida ‘Nonreligious Church’ Marketing COVID-19 ‘Cure’
  • Apr 20, 2020
    Physician Charged with Fraud for Selling COVID-19 'Miracle Cure'
  • Apr 15, 2020
    Fewer Doctors Are Prescribing Drugs Patients Request After Seeing DTC Ads
  • Apr 8, 2020
    Tissue Graft Supplier To Pay $6.5 Million To Resolve Allegations of False Pricing Disclosures to VA
  • Apr 7, 2020
    Court Refuses To Dismiss Criminal Fraud Charges Against Indivior
  • Apr 1, 2020
    District Court Dismisses Qui Tam Case Against Novartis Over Speaker Program
  • More

Good Clinical Practice

  • May 1, 2020
    ORI Wants Info on Sequestering Digital Research Misconduct Evidence
  • Apr 29, 2020
    JAMA Viewpoint Calls for Increased Public Access to FDA Inspection Reports
  • Apr 17, 2020
    FDA Updates COVID-19 Guidance for Clinical Trials; OHRP Issues New Guidance
  • Apr 10, 2020
    CDRH Sends Warning Letter To Sponsor-Investigator Over Significant Risk Device Trial
  • Apr 3, 2020
    FDA Ends Clinical Data Summary Pilot Program
  • Mar 27, 2020
    SACHRP: HHS Needs To Issue Guidance on License and Service Agreements for Apps Used in Research
  • Mar 20, 2020
    FDA, EMA Issue Guidance on Conducting Clinical Trials During COVID-19 Pandemic
  • Mar 13, 2020
    FDA Sends Warning Letter to Sponsor-Investigator for Conducting Study Without an IND
  • Mar 9, 2020
    FDA Releases Draft Guidance on Inclusion of Older Adults in Cancer Trials
  • Mar 5, 2020
    Wisconsin Governor Signs Bill Allowing Reimbursement of Cancer Trial Subjects’ Expenses
  • More

U.S. Food Labeling

  • Oct 25,2018
    Supplements Were Subject of Many Recent NAD Decisions
  • Oct 17,2018
    Study Says FDA Cited 100s of ‘Adulterated’ Supplements During 10-Year Period
  • Oct 10,2018
    Complaint Alleges Water Is Not as ‘Natural’ as Claimed
  • Oct 3,2018
    FDA Publishes RFI on Dairy Labeling of Plant-Based Products
  • Sep 27,2018
    Foundation Petitions FDA To Shut Down Use of ‘Non-GMO’ Label
  • Sep 20,2018
    ‘One a Day’ Vitamins Should Be Just That, California Appeals Court Says
  • Sep 13,2018
    FDA Is Rethinking Labeling of Honey, Maple Syrup as ‘Added Sugars’
  • Sep 4,2018
    FDA Supports Effort To Exempt Coffee From California's Required Cancer Warning
  • Aug 29,2018
    General Mills Agrees To Change Labeling on Granola Bars
  • Aug 23,2018
    NOSB Schedules Opportunities for Input on USDA’s Organic Program
  • More

FDA Regulation & Enforcement

  • Dec 21, 2023
    OPDP Researchers To Examine Implied Claims in DTC Drug Promotion
  • Dec 21, 2023
    Court Upholds Convictions for Off-Label Promotion of Device, Rejecting First Amendment Arguments
  • Dec 18, 2023
    FDA Updates Menu Labeling Guidance Regarding Added Sugars and TPP Nutrition Info
  • Dec 13, 2023
    Citizen Petition Calls for FDA To Remove ‘Misleading’ Promotional Claims From Botox Labeling
  • Dec 13, 2023
    Device Firm Official Pleads Guilty to Securities Fraud, Obstruction Over COVID-19 Test Fraud Scheme
  • Dec 8, 2023
    Sugarcane Variant Added to Bioengineered Foods List
  • Dec 6, 2023
    DOJ Official Outlines Practicalities of Consumer Protection Branch Voluntary Self-Disclosure Program
  • Dec 4, 2023
    FDA Gets Earful on Front-of-Package Labeling
  • Nov 29, 2023
    DOJ Asks Court To Dismiss Compounder Suit Seeking To Block FDA Enforcement Action, Adverse Publicity
  • Nov 29, 2023
    FDA Guidance Clarifies Yogurt Labeling Requirements
  • More

Medical Devices

  • Jul 8, 2021
    Avanos Medical $22 Million Settlement Resolves Charge of Fraudulently Misbranding Surgical Gowns
  • Jul 8, 2021
    In 2-1 Decision, D.C. Circuit Rules That FDA May Not Ban a Medical Device for a Particular Purpose
  • Jul 1, 2021
    Draft of Cures 2.0 Legislation Includes New Initiatives for Medical Device Regulation, Reimbursement
  • Jun 30, 2021
    HHS OIG: Device Maker’s Discount Program for Hospitals Would Not Raise Health Care Fraud Concerns
  • Jun 24, 2021
    Draft Guidance Is Intended To Explain Distinction Between Remanufacturing and Servicing a Device
  • Jun 16, 2021
    Legislation Would Restrict Regulation of LDT Procedures to CMS, Prohibit Any Oversight by FDA
  • Jun 10, 2021
    CDRH Discussion Paper May Lead to Additional Materials Labeling Requirements for Medical Devices
  • Jun 3, 2021
    FDA Warns Device Makers of Fraudulent EtO Sterilization Certificates Issued by Italian Facilities
  • Jun 2, 2021
    Medicrea Settlement Continues Emerging DOJ Trend of Including Open Payments Violation Allegations in Settlements
  • May 26, 2021
    Draft Guidance Documents Will Help Device Companies Meet Postmarket Surveillance Mandates, FDA Says
  • More

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