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Advertising & Promotion

  • Oct 31, 2020
    District Court Dismisses FCA Case Over Alleged Off-Label Marketing of Cancer Drug
  • Oct 23, 2020
    DOJ Reaches Global Settlement with Purdue Pharma
  • Oct 20, 2020
    Former Supplement Company Executives Sentenced to Prison Terms for Roles in Fraudulent Marketing
  • Oct 16, 2020
    Details of Mallinckrodt’s Global Opioid Settlement Released
  • Oct 15, 2020
    Gilead To Pay $97 Million To Resolve Kickback Allegations over Foundation Copays
  • Oct 15, 2020
    Former Compliance Officer’s Qui Tam Suit Leads to $18 Million Settlement with Merit Medical Systems
  • Oct 4, 2020
    OPDP Issues Two More Warning Letters
  • Sep 29, 2020
    Abrams Retires from OPDP
  • Sep 23, 2020
    Proposed Rule Outlines Evidence Relevant to FDA’s Determination of Intended Uses of Medical Devices
  • Sep 20, 2020
    OPDP Researchers To Examine Medical Conference Attendees’ Observations on Drug Promotion
  • More

Good Clinical Practice

  • Jan 19, 2021
    Recorded Phone Trial Recruitment Pitches Are OK
  • Jan 12, 2021
    Investigator Pleads Guilty to Conspiring To Falsify Trial Data
  • Jan 6, 2021
    FDA Issues Guidance on Individualized ASO Drug Trials
  • Dec 29, 2020
    DOJ Cites Iowa Center for ‘Uncontrolled and Unsupervised Experimentation’
  • Dec 23, 2020
    Master Protocols Added to Final FDA CID Guidance
  • Dec 16, 2020
    HHS Seeks SACHRP Nominations
  • Dec 10, 2020
    FDA Recommends How To Ensure Proper IP Disposal During Pandemic
  • Nov 30, 2020
    FDA Draft Guidance Offers Recommendations for DDI Studies with COCs and Acid-Reducing Agents
  • Nov 22, 2020
    PhRMA Issues Guidance for Enhancing Trial Diversity
  • Nov 17, 2020
    FDA Issues Final Guidance on Certificates of Confidentiality
  • More

U.S. Food Labeling

  • 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
  • Dec 10,2020
    Court Refuses To Enjoin Oklahoma Plant-Based Meat Labeling Law; Plaintiffs Appeal
  • Nov 24,2020
    House Passes Bill To Add Sesame to Regulated List of Allergens
  • Nov 12,2020
    FDA Posts Draft Guidance on Voluntary Disclosure of Sesame as Allergen
  • Oct 29,2020
    FDA Wants Feedback on Labeling ‘Nontraditional’ Sugars
  • More

FDA Regulation & Enforcement

  • Jan 13, 2021
    Court Shuts Down Supplement Company That Claimed Its Vitamin D Products Could Treat COVID-19
  • Jan 11, 2021
    N.Y. Assembly Bill Aims To Keep Individual Prescribing Data Confidential
  • Jan 7, 2021
    Congress Expands FDA’s Administrative Destruction Authority To Include Imported Medical Devices
  • 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
  • Jan 6, 2021
    FDA Debars Three Former Insys Executives
  • Dec 29, 2020
    Another Supplement Company and its Owner Plead Guilty to Charge of Marketing Unapproved SARMs
  • More

Medical Devices

  • Jan 14, 2021
    HHS Permanently Exempts Seven COVID-19-Related Medical Devices from FDA’s 510(k) Requirements
  • Jan 7, 2021
    Congress Expands FDA’s Administrative Destruction Authority To Include Imported Medical Devices
  • Jan 7, 2021
    FDA Finalizes Guidance for Program Offering Expedited Review for Devices with Safer Technologies
  • Dec 30, 2020
    FDA Finalizes Labeling Guidance, Updates Safety Communication on Laparoscopic Power Morcellators
  • Dec 24, 2020
    Device Company CEO Charged with Securities Fraud for Falsely Claiming Development of COVID-19 Test
  • Dec 16, 2020
    Catheter Maker Issues Urgent Recall of Device Following Reports of 14 Deaths, Hundreds of Injuries
  • Dec 10, 2020
    District Court: State Law Tort Claims Related to PMA Cardiac Device Are Not Preempted by Federal Law
  • Dec 2, 2020
    CISA: Cybersecurity Vulnerability in BD Alaris Infusion Pumps Could Affect Wireless Capability
  • Dec 2, 2020
    GAO Finds Persistent COVID-19 Supply Shortages, Inconsistent Testing Guidance from Federal Agencies
  • Nov 25, 2020
    Final Guidance on Microneedling Devices Reflects Class II Classification for Aesthetic Use Products
  • More

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