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Advertising & Promotion

  • May 28, 2021
    FDA, FTC Send Joint Warning Letters to Five Companies
  • May 26, 2021
    OPDP Encourages Grouped Electronic Submissions
  • May 20, 2021
    FTC Settles with CBD Marketer Over False Claims
  • May 10, 2021
    Massachusetts Sues Marketing Company Over Opioid Campaigns
  • May 6, 2021
    Drug Maker To Pay $12.6 Million To Resolve Allegations That It Illegally Paid Copays Through Foundation
  • May 3, 2021
    Indivior Completes Settlement with States Over Suboxone Marketing
  • Apr 29, 2021
    Supreme Court: FTC Cannot Obtain Restitution, Disgorgement Without Prior Administrative Proceeding
  • Apr 26, 2021
    OPDP Mandates eCTD Submission of Form FDA 2253 Starting in June
  • Apr 20, 2021
    Study Finds Device Company Payments to Physicians Are Larger Than Drug Company Payments
  • Apr 9, 2021
    Texas Bills Would Allow Off-label Promotion
  • More

Good Clinical Practice

  • Jul 1, 2021
    FDA Separates Sponsor and Investigator Safety Reporting Guidance
  • Jun 21, 2021
    NIA To Require Monthly Reporting on Trial Subjects
  • Jun 14, 2021
    Researchers Plead Guilty to Falsifying Trial Data
  • Jun 4, 2021
    SEC Settles with Investigator Over Insider Trading Related to Trial Results
  • May 28, 2021
    FDA’s Master Protocol Guidance Aids Sponsors of COVID-19 Products
  • May 26, 2021
    Draft Guidance Documents Will Help Device Companies Meet Postmarket Surveillance Mandates, FDA Says
  • May 21, 2021
    FDA Issues Draft Guidance on Investigator Statements
  • May 16, 2021
    ICH Clarifies Trial Statistical Principles
  • May 13, 2021
    Study Coordinator Charged with Falsifying Trial Data
  • May 2, 2021
    FDA Issues Notices of Noncompliance for Failure To Report Trial Results
  • More

U.S. Food Labeling

  • Dec 12,2019
    Association Develops Labeling Standard for Plant-Based Meats
  • Dec 5,2019
    CBD: To Be or Not To Be a Supplement Ingredient; Petition Seeks a Go-ahead From FDA
  • Nov 27,2019
    Consumer Group Seeks Enforcement Action Against Multiple Supplement Firms
  • Nov 21,2019
    FSIS Opens Docket on COOL Labeling Petition, Claims for Beef Products
  • Nov 14,2019
    Lawsuit Against Mississippi Vegan Meat Labeling Act Dropped After Regulatory Changes
  • Nov 7,2019
    New FOP Calorie Labeling Regs for Food in Glass-Front Vending Machines Published
  • Nov 4,2019
    Dr. Stephen Hahn Named as Next FDA Commissioner; Sharpless Returns to National Cancer Institute
  • Oct 31,2019
    ’Imitation’ Meat Labeling Act Introduced on Capitol Hill
  • Oct 24,2019
    AMS Describes More Changes Ahead for Organic Program’s National List
  • Oct 17,2019
    Physicians’ Group Wants FDA To Require Label on Cheese Warning of Possible Link to Breast Cancer
  • More

FDA Regulation & Enforcement

  • Jul 13, 2024
    District Court Finds ‘Manufactured in the USA’ Label False
  • Jul 13, 2024
    FDA To Exercise Enforcement Discretion for ‘Tailored’ Responses to Internet Misinformation
  • Jul 10, 2024
    HHS OIG: Refund, Discount Programs for Pediatric Immunodeficiency Drug Will Not Trigger Sanctions
  • Jul 5, 2024
    Appeals Court Sends Baby Food Nutrient Statement Case Back to Trial Court
  • Jul 3, 2024
    Former Employee Who Sued Pharma Distributor Asks Supreme Court To Clarify Anti-Kickback Statute
  • Jun 28, 2024
    Bakery Gets Warning Letter for Allegedly Including Allergens Among Ingredients When Allergens Are Not in the Product
  • Jun 27, 2024
    Kansas Sues Pfizer Over COVID-19 Vaccine Claims
  • Jun 26, 2024
    Report on FDA Infant Formula Response May Spur Reforms for Inspections, Recalls, Complaint Handling
  • Jun 19, 2024
    HHS OIG: Patient Assistance Provided by Gene Therapy Drug Manufacturer Will Not Result in Sanctions
  • Jun 19, 2024
    CEO Who Marketed Neurostimulation Device With Nonfunctioning Component Receives Six-Year Sentence
  • More

Medical Devices

  • Aug 2, 2022
    CDRH Launches eSTAR and eCopy Electronic Upload Capability for Device Premarket Submissions
  • Aug 2, 2022
    AdvaMed Urges Passage of Diagnostics Regulation Reform as Part of FDA User Fee Reauthorization
  • Aug 1, 2022
    Court Dismisses False Claims Case in Which DOJ Suggested Liability Could Be Based on FD&C Violations
  • Jul 29, 2022
    Device Maker Settles Kickback Allegations
  • Jul 28, 2022
    FDA Extends UDI Data Submission Enforcement Discretion for Class I, Unclassified Devices to Dec. 8
  • Jul 20, 2022
    FDA Call for Input on Benefits, Risks of Non-Device Medical Software May Lead to Increased Regulation
  • Jul 14, 2022
    District Court: Device-Related Personal Injury Claims as Presented in Complaint Are Preempted
  • Jul 13, 2022
    AdvaMed Report Recommends Strategies for Boosting Diversity in Medical Technology Clinical Research
  • Jul 6, 2022
    $1 Million Settlement Resolves DOJ Suit Against Device Distributor, Physician-Owned Distributorships
  • Jun 29, 2022
    DOJ Statement of Interest Links FD&C Act Violations to Possible Liability Under the False Claims Act
  • More

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