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Advertising & Promotion

  • Jul 5, 2023
    Final Guidance on Quantitative Efficacy and Risk Info in DTC Promotions Is Little Changed From Draft
  • Jun 29, 2023
    Ex-DePuy Sales Rep Charged With Defrauding Hospital, Lying to FBI About Sterilization Interference
  • Jun 28, 2023
    Connecticut To Require Companies With Sale Reps To Register
  • Jun 13, 2023
    OPDP Issues First Enforcement Letter in a Year
  • Jun 6, 2023
    FDA Proposes One-Page Patient Medication Information Notice
  • May 21, 2023
    Study Finds Responses to Drug Ads May Be ‘Overly Optimistic’ Without Disclosures
  • May 17, 2023
    Court Grants Summary Judgment to Device Company Accused of Wrongful Discharge of Sales Rep Over Off-label Marketing
  • May 2, 2023
    OPDP Researchers Move Ahead With Three Studies
  • Apr 25, 2023
    OPDP Researchers Plan Survey on How Consumers Interpret Specific Quantitative Claims
  • Apr 20, 2023
    Court: State Law Claims Involving Class II Device Cleared via De Novo Process Not Expressly Preempted
  • More

Good Clinical Practice

  • Oct 18, 2023
    CDER Seeks Opinions on Innovative Trial Approaches
  • Oct 7, 2023
    Two Investigators Receive Warning Letters Over Trial Concerns
  • Sep 26, 2023
    FDA Offers Recommendations on How To Deal With Major Trial Disruptions
  • Sep 20, 2023
    CVM Offers Informed Consent Guidance
  • Sep 13, 2023
    What Should IRBs Consider in Reviewing Individual Expanded Access Submissions?
  • Sep 6, 2023
    Clinical Investigator Receives Warning Letter Over Alleged Failure To Follow Protocol
  • Aug 29, 2023
    HHS Issues Draft Scientific Integrity Policy
  • Aug 21, 2023
    FDA Releases Long-Awaited Final Informed Consent Guidance
  • Aug 6, 2023
    WHO Proposes Clinical Trial Best Practices
  • Jul 31, 2023
    SACHRP Makes Recommendations on Draft FDA DCT and OHRP Limited IRB Review Guidances, Adds New Members
  • More

U.S. Food Labeling

  • Feb 16,2023
    USDA Strengthens Enforcement of Organic Rules
  • Feb 2,2023
    FDA Seeks Input on Designing FOP Labeling System
  • Jan 19,2023
    FSIS Rule Expands List of Products Qualifying for Generic Label Approval
  • Jan 5,2023
    FDA, FSIS Set Food Labeling Uniform Compliance Date
  • Jan 5,2023
    FDA Removes Stay on Yogurt Standard of Identity Provisions
  • Dec 30,2022
    FTC Expands Advertising Guide To Include All Health-Related Claims
  • Dec 22,2022
    Agencies Jointly Issue RFI for Input on Regulating Biotechnology
  • Dec 9,2022
    FDA Posts Clarifying Guidances on Food Allergen Labeling, Asks for Comments on 'Milk,' 'Eggs'
  • Nov 23,2022
    Cell Culture Food Gets First FDA Safety Go-Ahead
  • Nov 10,2022
    Court Enjoins Distribution of Adulterated, Misbranded Supplements
  • More

FDA Regulation & Enforcement

  • Jun 20, 2025
    Congress Introduces Bills To Ban DTC Drug Ads
  • Jun 18, 2025
    DOJ Revises Policy on Foreign Corrupt Practices Act Enforcement, With a Focus on U.S. Interests
  • Jun 14, 2025
    OPDP Warning Letter Alleges Instagram Post Lacked Risk Info
  • Jun 11, 2025
    HHS OIG: FDA Must Address Gaps in Domestic Food Facility Inspections
  • Jun 6, 2025
    Study Finds Increased Consumer Use of Nutrition Facts Labels
  • Jun 4, 2025
    Consent Decree Allows Evaluation of Company’s Claims That Products Are Devices, Not Unapproved Drugs
  • May 30, 2025
    Senator Questions FDA’s Commitment to DTC Oversight
  • May 30, 2025
    Pa. Legislature Considers Food Labeling Bills
  • May 26, 2025
    Physicians Ask Supreme Court To Review Decision Allowing FDA To Regulate Stem Cell Procedure
  • May 23, 2025
    OPDP Issues First Warning Letter in Nearly Two Years
  • More

Medical Devices

  • Jun 26, 2024
    CDRH Initiative Seeks To Reimagine the Home as Part of Health Care System To Advance Health Equity
  • Jun 19, 2024
    CEO Who Marketed Neurostimulation Device With Nonfunctioning Component Receives Six-Year Sentence
  • Jun 18, 2024
    AMA Calls for More Women and SGMs in Clinical Trials
  • Jun 12, 2024
    Clinical Lab Association, Member Company Sue To Block FDA’s Final Rule on LDTs
  • Jun 5, 2024
    Final Rule Implements FDA’s Authority To Destroy Some Devices That Are Refused Admission Into U.S.
  • Jun 5, 2024
    Innovasis, Two Company Officials To Pay $12 Million To Resolve False Claims, Kickback Allegations
  • May 29, 2024
    AdvaMed Wants FDA To Stress Role of Informal Communications With Agency As Well As Pre-Submissions
  • May 22, 2024
    Blood Lead Level Test Maker To Plead Guilty, Pay $42 Million for Concealing Devices’ Malfunctions
  • May 15, 2024
    AdvaMed Expresses Confidence That FDA Can Effectively Review, Regulate AI/ML-Enabled Devices
  • May 9, 2024
    FDA: Finalized Guidance Can Help Firms Distinguish Device Servicing From Device Remanufacturing
  • More

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