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Advertising & Promotion

  • Apr 8, 2021
    Ninth Circuit Allows Fraud-on-the-FDA Claim in False Claims Act Suit Brought Against Medtronic
  • Mar 31, 2021
    Boston Scientific Settles with States Over Marketing of Surgical Mesh Devices
  • Mar 21, 2021
    OPDP Researchers Move Ahead with Proprietary Name Study
  • Mar 15, 2021
    OPDP Issues First Untitled Letter of 2021
  • Mar 9, 2021
    NAD Provides Tips for Influencer Marketing
  • Mar 3, 2021
    OPDP Researchers Move Ahead with Study of Promotion of Multiple Indications in DTC TV Ads
  • Feb 19, 2021
    OPDP Issues Two Warning Letters To Start 2021
  • Feb 17, 2021
    EHR Developer Settles Kickback Case
  • Feb 6, 2021
    McKinsey Agrees to $573 Million Settlement Over Opioid Promotion
  • Feb 3, 2021
    Insys Therapeutics Founder Kapoor Settles with New Jersey in Opioids Lawsuit
  • More

Good Clinical Practice

  • Apr 28, 2021
    Researchers Need To Consider Effect of Remote Trial Options on Study Validity and Integrity
  • Apr 22, 2021
    SCRS Offers Trial Site Diversity Self-assessment Tool
  • Apr 21, 2021
    Guidance Heralds FDA’s Expanding Use of Remote Interactive Evaluations in Place of Inspections
  • Apr 9, 2021
    SACHRP Recommends Guidance on Restrictions of Data From Research Violating Human Subject Protections
  • Apr 3, 2021
    CBER Sends Untitled Letters To Two Investigators
  • Mar 29, 2021
    SACHRP Gives Advice on Interactions with Trial Subjects
  • Mar 23, 2021
    Research Center: IRBs Need To Promote Trial Diversity
  • Mar 15, 2021
    CDER Issues Third Clinical Investigator Warning Letter of 2021
  • Mar 11, 2021
    Florida Physician, Clinic Officials Face Multiple Charges for Allegedly Falsifying Clinical Trial Data
  • Mar 8, 2021
    BIMO Inspections Down a Third in FY 2020
  • More

U.S. Food Labeling

  • Oct 9,2019
    AMS Renews Various Substances on Organic Program’s National List
  • Oct 3,2019
    AMS Posts New BE Food Disclosure FAQs, Decision Tree
  • Sep 26,2019
    Congressional Letter Asks Sharpless to Make Haste on Allowing CBD in Food
  • Sep 18,2019
    Petition Seeks Changes to FSIS Labeling Regulations for Processed Meat
  • Sep 12,2019
    FDA Unveils New Submission System for Supplement NDINs, Claims
  • Sep 4,2019
    FDA Is Seeking Input on Updating Standards of Identity
  • Aug 29,2019
    Seafood Processor Pleads Guilty to Falsely Labeling Crabmeat
  • Aug 22,2019
    Guidance Posted on How to Measure, List Certain Items on Updated Labels
  • Aug 14,2019
    Study: Sesame Allergy More Widespread Than Previously Understood
  • Aug 5,2019
    Groups Support Challenge to Arkansas ‘Veggie’ Labeling Law
  • More

FDA Regulation & Enforcement

  • Jun 14, 2024
    BMJ Article Details Mallinckrodt’s Medical Information Strategies for Opioids
  • Jun 12, 2024
    Court Dismisses Suit Alleging Bottled Water Labeling Was Deceptive Due to Presence of Microplastics
  • Jun 11, 2024
    Consumer Survey Finds No Clear Winner Among FOP Label Schemes
  • Jun 5, 2024
    Final Rule Implements FDA’s Authority To Destroy Some Devices That Are Refused Admission Into U.S.
  • Jun 5, 2024
    Innovasis, Two Company Officials To Pay $12 Million To Resolve False Claims, Kickback Allegations
  • Jun 2, 2024
    JAMA Analysis Examines Physician Product Endorsements on X
  • May 30, 2024
    Court Allows Class Action Suit Against Pasta Maker Over Labeling
  • May 28, 2024
    Fifth Circuit: Impossibility Preemption Applied Where Label Change Via CBE Reg Was Not Available
  • May 22, 2024
    Blood Lead Level Test Maker To Plead Guilty, Pay $42 Million for Concealing Devices’ Malfunctions
  • May 22, 2024
    Former Employee of EHR Developer Sentenced for Trying To Obstruct Purdue Pharma Kickback Probe
  • More

Medical Devices

  • Jun 22, 2022
    FDA Launches eSTAR Electronic 510(k) Submission Pilot Program for CBER-Regulated Medical Devices
  • Jun 15, 2022
    Connecticut Supreme Court Recognizes State Duty To Report Device Adverse Events to the FDA
  • Jun 8, 2022
    Final Device Electromagnetic Compatibility Guidance Offers Transition Periods for Submission Content
  • Jun 1, 2022
    Senate HELP Committee Draft of Device User Fee Bill Revives In Vitro Test Regulation Proposals
  • May 25, 2022
    Pilot Program Could Help Streamline Transitions Away From Ethylene Oxide Sterilization for Devices
  • May 18, 2022
    DOJ: Device Firm Encouraged Use of Its Products on Multiple Patients with Reuse of Single-Use Disposables
  • May 11, 2022
    Voluntary Third-Party Device Quality Appraisal Program Will Offer Inspection, Submission Advantages
  • May 5, 2022
    FDA Proposes Order Directing Philips Respironics To Submit Plan for Handling Recalled Devices
  • May 4, 2022
    HHS OIG: Physician-Owned Device Firm Poses Little Risk of Illegal Kickbacks Despite 2013 Fraud Alert
  • Apr 19, 2022
    Four More Device Types Are Eligible for Safety and Performance Based Pathway Under New Guidance
  • More

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