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Advertising & Promotion

  • Jun 27, 2022
    Oregon Issues Permanent Rules for Drug Sales Rep Licensing
  • Jun 20, 2022
    FTC Enforcement To Focus on PBM Rebates and Fees
  • Jun 10, 2022
    Washington Supreme Court: Direct-to-Consumer Advertising Does Not Dilute Learned Intermediary Doctrine
  • Jun 7, 2022
    Third OPDP Untitled Letter of 2022 Cites Risk Presentation, Efficacy Claims
  • Jun 2, 2022
    Pfizer Reaches Kansas Settlement Over Co-pay Coupon Program
  • May 26, 2022
    Analysis Finds Drug Ad Spending Stagnant Since 2018
  • May 12, 2022
    Revised AdvaMed Code on Interactions with HCPs Becomes Effective June 1
  • Apr 29, 2022
    OPDP Researchers Will Conduct Tradeoff Analysis of Product Claims Made to Consumers and Physicians
  • Apr 18, 2022
    Marketers Sentenced for Roles in Compounded Drug Kickback Scheme Through Oklahoma Pharmacy
  • Apr 18, 2022
    District Court Dismisses Case Against Merck over Vaccine Marketing
  • More

Good Clinical Practice

  • Aug 19, 2022
    OIG Audit Finds NIH-funded Trials Not Posting Results
  • Aug 12, 2022
    SACHRP Asks for More Clarity in HHS Single IRB Guidance
  • Aug 1, 2022
    SACHRP Recommends New Definitions of ‘Engagement’ and ‘Support’
  • Jul 29, 2022
    Sponsor-investigator Receives FDA Warning Letter; BRANY Gets Determination Letter
  • Jul 24, 2022
    Two More Clinical Trial Staff Plead Guilty to Falsifying Data
  • Jul 20, 2022
    Abbott Funds Clinical Trial Diversity Program
  • Jul 13, 2022
    AdvaMed Report Recommends Strategies for Boosting Diversity in Medical Technology Clinical Research
  • Jul 8, 2022
    OHRP Issues Draft Guidance on Use of Single IRB for Cooperative Research
  • Jul 1, 2022
    HBCU-Pharma Project Will Create Clinical Trial Centers of Excellence
  • Jun 27, 2022
    HHS To Revise Research Misconduct Regulation
  • More

U.S. Food Labeling

  • Jul 22,2021
    FDA Releases Preview of Planned Upcoming Labeling Guidances
  • Jul 8,2021
    USDA Commits to Wholesale Review of ‘Product of USA’ Labeling
  • Jun 23,2021
    FDA Updates Standard of Identity for Yogurt Products
  • Jun 15,2021
    NOSB Will Meet in October
  • Jun 9,2021
    Supplement Firm Asks Court To Dismiss Class Action
  • May 26,2021
    AMS Releases Results of 2020 NOP Enforcement Activity
  • May 13,2021
    FDA Undertakes Research on ‘Healthy’ Symbols as Prelude to Regulations
  • Apr 29,2021
    FASTER Act Is Now Law; Adds Sesame to List of Major Allergens for Labeling
  • Apr 15,2021
    Appellate Court Will Not Enjoin Missouri Meat Labeling Law
  • Apr 15,2021
    FDA Offers Plan To Reduce Amount of Heavy Metals in Baby Food
  • More

FDA Regulation & Enforcement

  • Oct 9, 2024
    Vape Company Asks Court To Declare That FDA Civil Money Penalty Proceeding Violates Right to Jury Trial
  • Oct 8, 2024
    California To Standardize Quality, Safety Date Wording on Food Labels in 2026
  • Oct 3, 2024
    Stem Cell Company CEO Sentenced To Serve 36 Months in Prison for Distributing Unapproved Drug
  • Oct 2, 2024
    FDA Launches Office of Inspections and Investigations
  • Sep 27, 2024
    AI Company Reaches Agreement with Texas Over Marketing Claims
  • Sep 25, 2024
    DOJ Updates Tool for Evaluating Corporate Compliance Programs To Include Examination of How Firms Mitigate AI Risks
  • Sep 20, 2024
    Industry Concerned Draft Guidance on Responding to Misinformation Is Too Narrow and Raises First Amendment Issues
  • Sep 19, 2024
    Pharmacist Who Compounded Subpotent, Nonsterile Nuclear Drugs Pleads Guilty to Adulteration Charge
  • Sep 15, 2024
    AbbVie Receives Untitled Letter Over Ubrelvy TV Ad
  • Sep 11, 2024
    Device Maker To Pay $700K To Resolve Allegations of Encouraging Use of Incorrect Billing Codes
  • More

Medical Devices

  • Jul 19, 2023
    District Court: Failure-To-Warn Claim Survives Federal Preemption in Filshie Clip Litigation
  • Jul 12, 2023
    Diagnostics Firm Penalized by SEC for Allegedly Misleading Press Releases About a COVID-19 Test
  • Jul 12, 2023
    Trade Associations Want FDA To Provide More Guidance on Change Plans for AI-Enabled Devices
  • Jul 6, 2023
    Commenting on EPA’s EtO Proposals, AdvaMed Warns of Disruptions at Device Sterilization Facilities
  • Jun 29, 2023
    FDA: Pilot Program for Oncology Drugs Used With In Vitro Tests May Boost Reliability of Some LDTs
  • Jun 29, 2023
    Ex-DePuy Sales Rep Charged With Defrauding Hospital, Lying to FBI About Sterilization Interference
  • Jun 13, 2023
    Guidance Finalizes FDA’s Recommendations for Premarket Submissions for Device Software Functions
  • Jun 12, 2023
    AdvaMed Urges Public, Private Action To Boost the Resilience of the Medical Technology Supply Chain
  • 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
  • More

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