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Advertising & Promotion

  • Aug 14, 2020
    Congressional Bills Seek Opioid Sales Rep Licensure; State Bills Would Ban HCP Gifts
  • Aug 7, 2020
    Citizen Petition Requests FDA Ban on Music During Risk Presentation in DTC Ads
  • Jul 31, 2020
    Pacira Settles Kickback Allegations Over Research Grants
  • Jul 29, 2020
    Indivior Agrees To Plead Guilty, Pay $600 Million as Part of Largest-Ever DOJ Settlement Involving an Opioid
  • Jul 28, 2020
    Device False Advertising Claims Dismissed
  • Jul 20, 2020
    OPDP Posts Three Case Studies To Help HCPs Identify ‘Bad Ads’
  • Jul 10, 2020
    FDA To Use COVID-19 Risk Assessment System As It Restarts Domestic Inspections; Most Will Be Preannounced
  • Jul 10, 2020
    OPDP Researchers Plan Three New Studies
  • Jul 3, 2020
    Novartis To Pay Nearly $700 Million To Settle Speaker Program and Co-Pay Cases
  • Jul 1, 2020
    Novartis, Subsidiaries Settle Foreign Corrupt Practices Act Allegations for Over $345 Million
  • More

Good Clinical Practice

  • Aug 27, 2020
    MRCT Center Releases Guidance, Toolkit To Improve Diversity, Inclusion and Equity in Clinical Trials
  • Aug 17, 2020
    FDA Issues Final Guidance on Civil Money Penalties for ClinicalTrials.gov Reporting Violations
  • Aug 12, 2020
    Eight Individuals Indicted for Alleged Clinical Research Fraud Against FDA, Pharmaceutical Companies
  • Aug 7, 2020
    Cancer Groups Look To Improve Minority Participation in Trials
  • Aug 4, 2020
    SACHRP Addresses Ethics of Research Involving Disadvantaged Populations, Risks to Bystanders, Public Health Surveillance
  • Jul 31, 2020
    Pacira Settles Kickback Allegations Over Research Grants
  • Jul 26, 2020
    SACHRP Recommends Penalties for Misuse of Subject Data
  • Jul 17, 2020
    FDA Releases Four Final Guidances on Cancer Clinical Trial Eligibility Criteria
  • Jul 10, 2020
    FDA To Use COVID-19 Risk Assessment System As It Restarts Domestic Inspections; Most Will Be Preannounced
  • Jul 10, 2020
    FDA Updates Informed Consent Recommendations in COVID-19 Guidance
  • More

U.S. Food Labeling

  • Feb 20,2019
    AMS Proposes To Add, Reclassify Substances on National Organic List
  • Feb 14,2019
    FDA Begins Efforts To ‘Modernize’ Dietary Supplement Oversight
  • Feb 7,2019
    House Members Want FDA To Take Action on ‘Dairy’ Labeling
  • Jan 29,2019
    Petition Seeks Ban on Certifying Hydroponic Products as Organic
  • Jan 23,2019
    Firm Recalls Chicken Products Due to Undeclared Allergen
  • Jan 17,2019
    New York Attorney General Finds Widespread Seafood Mislabeling
  • Jan 3,2019
    AMS Publishes Bioengineered Food Disclosure Standard
  • Dec 21,2018
    FDA Issues Technical Amendments to Facts Panel Revisions
  • Dec 18,2018
    Gottlieb Says New Policies May Be Coming To Improve Supplement Oversight
  • Dec 17,2018
    FDA Withdraws Proposed Rule That Would Have Allowed Unilateral Changes to Generic Drug Labeling
  • More

FDA Regulation & Enforcement

  • Feb 20, 2024
    Drug Manufacturer To Pay $750,000 To Resolve Allegations of Paying Indirect Kickbacks to Doctor
  • Feb 19, 2024
    Senators Want FDA Action on Social Media Drug Promotions
  • Feb 15, 2024
    Firm Pleads Guilty, Will Pay More Than $23M for Shipping Veterinary Rx Drugs to Unauthorized End Users
  • Feb 9, 2024
    Bill To Ban Advertisement of Drugs Directly to the Public Introduced in Kentucky House
  • Feb 8, 2024
    Revised Draft Guidance on Remote Regulatory Assessments Incorporates Public Comments, Changes to Law
  • Feb 2, 2024
    Advertising Agency Settles Litigation With States Over Opioid Marketing
  • Feb 2, 2024
    Bills Look To Rein In Labeling for Egg Alternatives
  • Feb 1, 2024
    Former Device Firm Employee Who Forged FDA 510(k) Clearance Letters Will Serve 12 Months in Prison
  • Jan 26, 2024
    Flanders Adopts ‘Animal-Friendly’ Food Labels
  • Jan 25, 2024
    Senators Ask GAO To Review FDA Oversight of Recalls in Wake of Philips Respironics Device Problems
  • More

Medical Devices

  • Oct 27, 2021
    CDRH To Develop Guidance on Transition of Devices from COVID-19 EUAs, Enforcement Discretion Policies
  • Oct 21, 2021
    Fifth Circuit Affirms Dismissal on Preemption Grounds of Tort Claims Stemming from ICD Failure
  • Oct 13, 2021
    FDA Plans Not To Enforce GUDID Data Submission Mandates for Class I Consumer Health Product Devices
  • Oct 5, 2021
    Final Rule Establishes Submitter Requirements, Review Procedures for De Novo Classification Pathway
  • Sep 29, 2021
    FDA Moves Closer to Requiring All Submissions for 510(k) Devices To Be Provided in Electronic Format
  • Sep 22, 2021
    FDA Begins Posting Safety Data Reports on Materials Typically Used in Implantable Medical Devices
  • Sep 16, 2021
    DOJ Urges Full D.C. Circuit Review of Decision Barring FDA from Banning Particular Uses of Devices
  • Sep 16, 2021
    Regulation of Devices That Process Autologous HCT/Ps at the Point of Care Is Consolidated in CBER
  • Sep 8, 2021
    Spine Device Maker, Two Company Officials Indicted on Kickback, Conspiracy, Money Laundering Charges
  • Sep 2, 2021
    Tennessee Court: Liability Claims Involving Hybrid Devices with PMA, 510(k) Components Are Preempted
  • More

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