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Advertising & Promotion

  • Jan 27, 2021
    Acting Director Wants OPDP To Be More Visible
  • Jan 22, 2021
    Woodcock Becomes Acting FDA Commissioner Following Hahn’s Resignation as Biden Administration Begins
  • Jan 21, 2021
    Journal Article Scrutinizes Nurse Ambassador Programs
  • Jan 11, 2021
    N.Y. Assembly Bill Aims To Keep Individual Prescribing Data Confidential
  • Jan 6, 2021
    FDA Debars Three Former Insys Executives
  • Dec 29, 2020
    Senate Report Calls for Adding Payments to Tax-exempt Groups to Open Payments Database
  • Dec 21, 2020
    Drug Company and Specialty Pharmacy Settle False Claims Act Case Over Payments to Foundations
  • Dec 16, 2020
    OPDP Researchers Move Ahead with Endorsement Studies, Report on Completed Research
  • Dec 4, 2020
    OPDP Issues Second Untitled Letter of 2020
  • Dec 2, 2020
    Companies Settle FCA Case Over Improper Promotion of Drug-Device Combo Product for Pediatric Use
  • More

Good Clinical Practice

  • Mar 3, 2021
    Questions Over Investigational Drug, Informed Consent Result in Warning Letter
  • Feb 24, 2021
    Illinois Bill Calls for Medicaid Coverage of Routine Care Costs in Clinical Trials
  • Feb 17, 2021
    Clinical Investigator Receives Warning Letter for Not Following Trial’s Investigational Plan
  • Feb 11, 2021
    Senators: FDA Should Investigate Inaccuracies in Oximeter Blood Oxygen Readings Among Persons of Color
  • Feb 6, 2021
    CTTI Issues COVID-19 Clinical Trial Playbook
  • Feb 2, 2021
    FDA Issues Guidance on Conducting BE Studies During COVID Pandemic
  • Jan 28, 2021
    Group Provides Recommendations for Inclusion of Pregnant Women in Vaccine Research
  • Jan 22, 2021
    Woodcock Becomes Acting FDA Commissioner Following Hahn’s Resignation as Biden Administration Begins
  • Jan 19, 2021
    FCC: Recorded Phone Trial Recruitment Pitches Are OK
  • Jan 12, 2021
    Investigator Pleads Guilty to Conspiring To Falsify Trial Data
  • More

U.S. Food Labeling

  • Jul 31,2019
    FSIS Rejects Request to Require New Warning on Processed Meat, Poultry Labels
  • Jul 25,2019
    Seafood VP Pleads Guilty to Conspiracy To Mislabel Millions of Dollars, Tons of Dollars of Crab
  • Jul 18,2019
    Demands for FDA To Act on Plant-Based Labeling Continue Apace
  • Jul 11,2019
    Oatly, Supplement Maker Back Away from Challenged Claims
  • Jul 11,2019
    More Time Given for Feedback on Potassium Chloride in Food Labeling
  • Jul 11,2019
    FSIS Provides Guidance on Kit Products
  • Jul 11,2019
    Groups Sue To Stop Implementation of Mississippi 'Veggie' Law
  • Jul 3,2019
    Following Trend, Court Holds That Calling Soda ‘Diet’ Does Not Promise Weight Loss
  • Jun 26,2019
    FDA Gives Go-ahead to Use of Qualified Health Claims for EPA, DHA
  • Jun 20,2019
    Guidance Issued for Labeling Single-Ingredient Honey, Syrup, Cranberries
  • More

FDA Regulation & Enforcement

  • May 15, 2024
    DOJ Brings First Enforcement Action Involving Adulterated, Misbranded Weight Loss Drug Semaglutide
  • May 11, 2024
    Bakeries Issued Warning Letters Alleging Labeling Violations
  • May 8, 2024
    HHS OIG: Patient Assistance Charity Funded by Drug Companies Will Not Trigger Anti-Kickback Sanctions
  • May 6, 2024
    Prominently Disclosing Study Rigor May Aid Promotional Claims
  • May 1, 2024
    DOJ Launches Pilot Program Offering NPAs to Individuals Who Self-Disclose Criminal Conduct
  • Apr 26, 2024
    FDA Issues Revised Guidance on Promotion of Biosimilars
  • Apr 24, 2024
    Products Liability Suit Involving Recalled Implanted Defibrillator Implicated in Death Is Dismissed
  • Apr 23, 2024
    Endo Health Solutions Pleads Guilty to Marketing Opioid as Abuse Deterrent Without Supporting Data
  • Apr 22, 2024
    Bill To Require FOP Warning Labels Introduced in Senate
  • Apr 18, 2024
    District Court Dismisses Labeling Case Against Dole Fruit Products
  • More

Medical Devices

  • Apr 15, 2022
    FDA Wants Authority To Require Device Cyber Threat Protections, More Product Shortage Notifications
  • Apr 12, 2022
    Revamped FDA Draft Guidance Updates Recommendations for Addressing Device Cybersecurity in Premarket Submissions
  • Apr 7, 2022
    Fifth Circuit Affirms Dismissal of Louisiana Tort Law Claims Brought Against ICD Manufacturer
  • Mar 30, 2022
    Draft MDUFA V Performance Goals Would Help Speed Device Premarket Reviews, Guidance Development
  • Mar 24, 2022
    FDA Begins Product Transitions from Drug Status to Device Status in Wake of Appeals Court Decision
  • Mar 17, 2022
    FDA Issues 518(a) Order Requiring Philips To Fix ‘Inadequate’ Device Recall Notification Program
  • Mar 17, 2022
    OIG: Device Firm’s Cost-Sharing Subsidies for Clinical Study Would Pose Only Minimal Risk of Fraud
  • Mar 9, 2022
    FDA Warns Against Cyber Vulnerabilities in Remote Connectivity Software Used in ‘Numerous’ Devices
  • Mar 2, 2022
    Qui Tam Suit Targeting Medtronic Proctorships, Other Business Practices Survives Motion To Dismiss
  • Feb 22, 2022
    Revised Device Quality System Regulation Would Incorporate ISO 13485 Requirements by Reference
  • More

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