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Advertising & Promotion

  • 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
  • Sep 16, 2020
    OPDP Issues Warning Letter Over Radio Ad
  • Sep 10, 2020
    Former Indivior Medical Director Pleads Guilty to Misbranding Charge Brought Under Park Doctrine
  • Sep 9, 2020
    Judge Grants Preliminary Injunction in Marketing Case
  • Sep 2, 2020
    DUSA Pharmaceuticals To Pay $20.75 Million To Resolve Allegations That It Promoted Unapproved Administration of Its Drug
  • Aug 28, 2020
    OPDP Issues First 2020 Untitled Letter Over DTC TV Ad for Diabetes Product
  • Aug 21, 2020
    AbbVie Settles California Insurance Suit Over Promotion of Humira
  • Aug 14, 2020
    Specialty Pharmacy Agrees to $3.5 Million Settlement of Kickback Allegations Involving Teva Drug
  • More

Good Clinical Practice

  • Oct 23, 2020
    OHRP Allows Single IRB Review Exception for Some COVID-19 Research
  • Oct 20, 2020
    Investigator Sentenced to More Than 28 Years for Falsifying Clinical Trial Safety and Efficacy Data
  • Oct 13, 2020
    NHLBI Trial Changes Protocol and Informed Consent After Public Citizen Complaint to OHRP
  • Oct 8, 2020
    NIH Launches COVID-19 Outreach Program Targeting Minority Communities
  • Oct 1, 2020
    Study Finds Elderly Excluded from COVID-19 Trials
  • Sep 23, 2020
    Revised Guidance Details Investigator Review of Safety Reports in Trials Conducted During Pandemic
  • Sep 16, 2020
    FDA Issues Guidance on Measuring and Analyzing Common COVID-19 Symptoms in Clinical Trials
  • Sep 9, 2020
    ACRO Publishes Manual and Toolkit for Conducting Decentralized Clinical Trials
  • Sep 9, 2020
    Draft Guidance Offers Recommendations for Capturing Patient Perspectives When Developing, Evaluating Devices
  • Sep 3, 2020
    FDA Releases Draft Guidance on Clinical Trial Designs for CNS Metastases Treatments
  • More

U.S. Food Labeling

  • Apr 18,2019
    FDA Creates ‘Advisory List’ for Dietary Supplements
  • Apr 11,2019
    Meeting Scheduled on Changes in Supplement Industry as Part of FDA's Modernization of Regulatory Oversight
  • Apr 8,2019
    Next FDA Head Will Confront Full Agenda of Labeling Topics
  • Apr 4,2019
    FDA Intends To Add Another NDC to ‘Dietary Fiber’ Definition
  • Mar 28,2019
    Legislation Introduced to Stop Nondairy ‘Milk’ Labeling
  • Mar 21,2019
    Petition Wants FDA to Revise Nutrient Content Regulations
  • Mar 13,2019
    USDA, FDA Provide Details on Sharing Oversight of Cell Cultured Food
  • Mar 12,2019
    NCI Director Sharpless To Serve as Acting FDA Commissioner Following Gottlieb’s Departure
  • Mar 5,2019
    Gottlieb Resigns as FDA Commissioner
  • Feb 28,2019
    Petition Asks for Dairy Labeling Enforcement, Offers FDA Regulatory Suggestions
  • More

FDA Regulation & Enforcement

  • Mar 20, 2024
    FDA Revokes Standards of Identity and Quality for Frozen Cherry Pie
  • Mar 19, 2024
    UK Starts Consultation on Food Labeling
  • Mar 18, 2024
    CVM Issues Warning Letter Over Alleged Claims Made for New Animal Drug
  • Mar 14, 2024
    FSIS Issues ‘Product of USA’ Label Claim Rule
  • Mar 13, 2024
    Jury Returns Verdict Against CEO of Firm That Marketed Neurostimulation Device With Phony Component
  • Mar 6, 2024
    Cheese Company, Former Owner Plead Guilty to Charges Related to Listeria Outbreak That Killed Two
  • Mar 5, 2024
    NJ Appeals Court Dismisses Cases Alleging Unlawful Marketing
  • Mar 5, 2024
    FDA OKs Qualified Health Claims for Yogurt
  • Feb 29, 2024
    New Zealand Revises Food Labeling Regs To Add Allergy Information
  • Feb 28, 2024
    Family Dollar Stores Pleads Guilty to Shipping Rodent-Infested FDA-Regulated Products From Warehouse
  • More

Medical Devices

  • Dec 15, 2021
    Discussion Paper on 3D Printing Devices at Point of Care Presents Possible Scenarios for Regulation
  • Dec 8, 2021
    FDA: Playbook Resource Can Help Device Companies Perform Cybersecurity, Safety Threat Modeling
  • Dec 3, 2021
    OIG Opinion OKs Sponsor Picking Up Medicare Beneficiary Costs in Clinical Trial
  • Nov 29, 2021
    FDA Updates eSTAR Portals for De Novos, 510(k)s
  • Nov 22, 2021
    DOJ: Orthopedic Device Development Royalties Dispute with Surgeon Evolved into Illegal Kickback Scheme
  • Nov 18, 2021
    Biden Nominates Dr. Robert Califf To Head the FDA Again as Commissioner of Food and Drugs
  • Nov 17, 2021
    FDA Toughens Requirements for New COVID-19 Tests as HHS Reverses Trump Policy on LDT Reviews
  • Nov 11, 2021
    Draft Guidance Provides Recommendations for Content of Premarket Submissions for Device Software
  • Nov 1, 2021
    FDA, Health Canada, MHRA Issue Guiding Principles for Development of Good Machine Learning Practice
  • Nov 1, 2021
    Florida Device Firm Pleads Guilty to Dealing in Unapproved HA Devices, Agrees to Forfeiture
  • More

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