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Advertising & Promotion

  • 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
  • Oct 27, 2022
    Lower Percentage of OPDP Core Launch Reviews Met 45-Day Goal During FY 2022
  • Oct 20, 2022
    OPDP Researchers Move Ahead with Text Analysis of Proprietary Drug Name Interpretations
  • Oct 12, 2022
    Appeals Court Rejects Missouri Case Over Alleged Marketing Misrepresentation
  • Oct 12, 2022
    EEOC Sues Lilly Over Age Discrimination in Hiring Sales Reps
  • More

Good Clinical Practice

  • 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
  • Jan 18, 2023
    Research Coordinator Sentenced to Three Years in Prison for Lying During FDA Inspection
  • Jan 6, 2023
    Omnibus Spending Act Includes Clinical Trial Mandates
  • Dec 30, 2022
    ICH Proposes Harmonized Protocol Standard
  • Dec 23, 2022
    Investigator Receives Warning Letter Over Failure To Follow Investigational Plan
  • Dec 19, 2022
    CTTI Calls for Embedding Clinical Trials into Clinical Practice
  • Dec 13, 2022
    Analysis Finds Both Under- and Overrepresentation of Demographic Groups in U.S. COVID Trials
  • More

U.S. Food Labeling

  • 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
  • Feb 3,2022
    Online Food Retailers Are Not Satisfying Labeling Requirements
  • Feb 3,2022
    FDA Lists Food Guidances Under Consideration
  • Feb 3,2022
    Bills Introduced in Congress for Date, CBD Food Labeling
  • Feb 3,2022
    FASTER Act Video Is Now Available
  • Jan 18,2022
    FDA Allows Health Claim for Magnesium and Risk of Hypertension, Revokes Identity Standard for French Dressing
  • Jan 6,2022
    Ready or Not, Bioengineered Food Labeling Is Now in Effect
  • Dec 22,2021
    FDA Gives Go-ahead to Peanut Health Claim, Signals Intent To Include Gum Acacia as Dietary Fiber
  • More

FDA Regulation & Enforcement

  • Mar 28, 2025
    FDA Answers Questions on Food Allergen Labeling
  • Mar 27, 2025
    Senate Votes To Confirm Makary as FDA Commissioner
  • Mar 26, 2025
    Study: Nearly a Third of Device Manufacturer Adverse Event Reports Do Not Meet Regulatory Deadlines
  • Mar 26, 2025
    Former Magellan CEO Joins Other Execs in Pleading Guilty to Charge Related to Faulty Blood Lead Tests
  • Mar 21, 2025
    State Legislatures Consider Bills That Would Ban DTC Ads
  • Mar 19, 2025
    Ice Cream Manufacturer Enters Into Consent Decree Following cGMP Violations, Discovery of Pathogen
  • Mar 17, 2025
    CVM Issues First Advertising Enforcement Letters of 2025
  • Mar 12, 2025
    Court Grants Summary Judgment to Allergan on Kickback-Based False Claims, Off-Label Allegations
  • Mar 7, 2025
    Alleged Lack of Risk Info on Exhibit Panel Nets Untitled Letter
  • Mar 5, 2025
    Two Former Magellan Executives Enter Plea Agreements Related to Blood Lead Level Test Malfunctions
  • More

Medical Devices

  • Jan 10, 2024
    FDA Encourages Use of Vaporized Hydrogen Peroxide as Alternative to EtO for Device Sterilization
  • Jan 4, 2024
    OIG: Subsidies for Study Participants Covered by Medicare Would Not Pose Undue Risk of Fraud, Abuse
  • Jan 3, 2024
    CDRH Begins Issuing Export Documents in Electronic Form, Offers Online Authenticity Verification
  • Dec 21, 2023
    Draft Guidance Describes How FDA Evaluates RWD To Determine Usefulness of RWE in Its Decision-Making
  • 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
  • More

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