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Advertising & Promotion

  • Mar 17, 2022
    Jury Recommends Nearly $45 Million in Damages in False Advertising Case
  • Mar 9, 2022
    Sackler Family Settles with Eight States, D.C. Over Opioid Marketing
  • Mar 3, 2022
    OPDP Researchers Detail Studies Planned in 2022
  • Feb 23, 2022
    OPDP Issues First 2022 Warning Letter Over Video Promoting Investigational New Drug
  • Feb 17, 2022
    Seven Senators Urge DOJ to Investigate Sacklers
  • Feb 15, 2022
    Senate Narrowly Confirms Califf as FDA Commissioner
  • Feb 4, 2022
    More States, Tribes Settle Lawsuits Over Opioid Marketing
  • Jan 28, 2022
    OPDP Issues First Untitled Letter of 2022
  • Jan 21, 2022
    Bill To Remove DTC Prescription Drug Advertising Deduction Introduced in US House
  • Jan 14, 2022
    OPDP Reminds Companies in Untitled Letter That Complete Promotions Must Be Submitted
  • More

Good Clinical Practice

  • May 6, 2022
    FDA User Fee Bill Would Require Diversity Action Plans for Clinical Trials
  • Apr 29, 2022
    Eight-Year OHRP Review Ends With Determination Letter; Investigator Gets FDA Warning Letter
  • Apr 18, 2022
    FDA Permanently Debars Clinical Investigator, Clinical Study Coordinator for Fabricating Trial Data
  • Apr 15, 2022
    FDA Recommends Race and Ethnicity Diversity Plan for Trials
  • Apr 13, 2022
    Bills Requiring Drug Trial Cost Reporting Introduced
  • Apr 2, 2022
    FDA Issues Three Final Guidances To Aid Cancer Trials
  • Mar 25, 2022
    SACHRP: Research Enterprise Needs To Do More To Protect Non-subjects
  • Mar 18, 2022
    OHRP Issues First Determination Letters Since 2020; Investigator Receives FDA Warning Letter
  • Mar 17, 2022
    OIG: Device Firm’s Cost-Sharing Subsidies for Clinical Study Would Pose Only Minimal Risk of Fraud
  • Mar 14, 2022
    FDA Permanently Debars Two Clinical Trial Site Staff Members
  • More

U.S. Food Labeling

  • Feb 4,2021
    Suits Filed Against Chain Stores Allege Improper Labeling of Store-Brand Products
  • Jan 28,2021
    Ninth Circuit Rejects on Preemption Grounds Allegation that Biotin Structure/Function Claim Was Deceptive
  • Jan 22,2021
    Woodcock Becomes Acting FDA Commissioner Following Hahn’s Resignation as Biden Administration Begins
  • Jan 21,2021
    FTC, FDA Move Against Dozens of Supplement Firms Making False COVID-19 Claims
  • Jan 7,2021
    ANPR Issued on USDA’s Oversight of Genetically Engineered Animals
  • Jan 7,2021
    Petition Seeks Dietary Fiber Consideration for Gum Acacia
  • Jan 7,2021
    FDA Sets New Food Labeling Uniform Compliance Date
  • Jan 7,2021
    Supplement Firm Owner Pleads Guilty to Drug Distribution
  • Jan 7,2021
    FDA Warns Retailer About Undeclared Allergens
  • Dec 23,2020
    FDA Finalizes Labeling Guidance on Alternate Name for Potassium Chloride
  • More

FDA Regulation & Enforcement

  • Dec 11, 2024
    CDRH Provides Early Alert of Potentially High-Risk Device Recall Under Pilot Program
  • Dec 10, 2024
    Public Citizen Asks FTC To Examine Dr. Oz’s iHerb Social Media Posts
  • Dec 6, 2024
    FDA, FSIS Want Information on Food Date Labeling
  • Nov 29, 2024
    FSIS Sets Jan. 1, 2028, as Next Uniform Compliance Date for New Labeling Regs
  • Nov 27, 2024
    GAO: Attrition Among FDA Investigator Workforce Hampers Agency’s Ability To Meet Inspection Goals
  • Nov 27, 2024
    Appeals Court Upholds Dismissal of Complaint Alleging Fruit Cup Labeling Was False
  • Nov 25, 2024
    Trump Names Dr. Marty Makary To Lead FDA
  • Nov 20, 2024
    Citing Preemption and Ohio Tort Law, Court Dismisses Claims Related to Cervical Disk Device Failure
  • Nov 20, 2024
    QOL Medical, CEO To Pay $47 Million To Resolve False Claims Allegations Stemming From Free Lab Tests
  • Nov 15, 2024
    OPDP Issues Untitled Letter Over Instagram Post
  • More

Medical Devices

  • Jun 7, 2023
    FDA Seeks To Boost Health Equity, At-Home Use of Medtech With Call for Public Comment, PEAC Meeting
  • Jun 1, 2023
    Public Interest Groups Urge FDA To Regulate Laboratory-Developed Tests If Congress Will Not Act
  • May 31, 2023
    Court Enters Judgment of Nearly Half a Billion Dollars Against Lens Distributor in Kickback Case
  • May 25, 2023
    Progress of Pre-Submissions for Medical Devices Can Now Be Tracked Through FDA’s CDRH Portal
  • May 24, 2023
    $400K Settlement Resolves Allegations That Zoll Medical Illegally Sold China-Made ECG Cables to Feds
  • May 18, 2023
    Philips To Pay Over $62 Million To Resolve Alleged Foreign Corrupt Practices Violations in China
  • May 10, 2023
    FDA Postpones Enforcement of New Premarket Submission Requirements for Cyber Devices Until Oct. 1
  • May 2, 2023
    House Bill Would Guarantee Four Years of Medicare Coverage for New Breakthrough Devices
  • Apr 26, 2023
    Citing Express Preemption, Court Dismisses Claims Brought Against Pacemaker Manufacturer by Patient’s Estate
  • Apr 20, 2023
    Court: State Law Claims Involving Class II Device Cleared via De Novo Process Not Expressly Preempted
  • More

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