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Advertising & Promotion

  • Jun 26, 2020
    Feds Charge Regeneron with Providing Kickbacks Through Foundation Covering Medicare Co-pays
  • Jun 18, 2020
    Appeals Court Upholds Invalidation of Rule Requiring Price Disclosures in DTC TV Ads
  • Jun 17, 2020
    DOJ Intervenes in Qui Tam Suit Accusing Merit Medical Systems of Paying for Providers’ Advertising
  • Jun 12, 2020
    FDA Clarifies Policy on Distribution of Drug Samples During COVID-19 Pandemic
  • Jun 11, 2020
    California Diagnostic Test Company President Charged with Health Care, Securities Fraud
  • Jun 10, 2020
    Updated DOJ Guidance Provides Action Items for Corporate Personnel in Charge of Compliance Programs
  • Jun 8, 2020
    District Court Unseals Qui Tam Complaint Against Novo Nordisk over Promotion of Hemophilia Product
  • Jun 2, 2020
    BMJ Analysis Finds That Most Medical Association Leaders Have Financial Ties to Industry
  • May 21, 2020
    OPDP’s Bad Ad Program To Add Case Studies
  • May 13, 2020
    AdvaMed Offers New Compliance Guidance for Device Companies’ Response to COVID-19 Emergency
  • More

Good Clinical Practice

  • Jul 3, 2020
    FDA Guidance Examines Key COVID-19 Vaccine Trial Issues
  • Jun 28, 2020
    Number of FDA BIMO Inspections Decreased in FY 2019
  • Jun 19, 2020
    Sponsors Need To Plan for COVID-19's Effect on Clinical Trial Objectives
  • Jun 12, 2020
    CRS Provides Congress with Options for Providing Direction to FDA on COVID-19 Vaccine Trials
  • Jun 10, 2020
    Updated DOJ Guidance Provides Action Items for Corporate Personnel in Charge of Compliance Programs
  • Jun 5, 2020
    FDA Issues Guidance on IRB Review of Expanded Access Requests; Updates COVID-19 Trial Guidance
  • May 29, 2020
    Three States Authorize Medicaid Coverage for Clinical Trial Routine Care Costs
  • May 22, 2020
    Campaign Launched To Increase Clinical Trial Diversity
  • May 17, 2020
    FDA Expands COVID-19 Clinical Trial Guidance, Offers New Guidance on Developing Treatment and Prevention Products
  • May 11, 2020
    ACRP Launches Program To Aid Site Staff Training and Development as Pandemic Takes Toll on Trial Sites
  • More

U.S. Food Labeling

  • Dec 12,2018
    FDA Offers Training on Menu Labeling
  • Dec 12,2018
    FDA, Industry Cooperate on Labeling To Prevent Spread of Illness
  • Dec 12,2018
    Farm Bill Offers Syrup, Honey Products Relief From Added Sugars Declaration
  • Dec 12,2018
    FSIS Issues Uniform Compliance Date for Labeling Regulations
  • Dec 6,2018
    FDA Gives Go-Ahead to Oleic Acid, CHD Qualified Health Claim
  • Nov 27,2018
    AMA Asks FDA for FOP Warning Labels for Added Sugars
  • Nov 20,2018
    FDA, USDA Agree To Share Regulation of Cell Cultured Food Products, Extend Time To Comment
  • Nov 14,2018
    Groups Ask Court To Stop Enforcement of Missouri ‘Meat’ Labeling Law
  • Nov 8,2018
    FDA Posts Two Guidances on New Facts Panels
  • Oct 30,2018
    FDA Takes First Step Toward Allergen Labeling for Sesame
  • More

FDA Regulation & Enforcement

  • Jan 24, 2024
    Court Dismisses Challenge to OIG Advisory Opinion Rejecting a Coalition Model of Patient Assistance
  • Jan 23, 2024
    OPDP Issues First Untitled Letter for 2024; Efficacy Claims Continue as Agency Focus
  • Jan 17, 2024
    GAO Calls for More FDA Oversight of Dietary Supplements
  • Jan 17, 2024
    Distributor of Misbranded Workout Supplements Pleads Guilty, Agrees to $4.5 Million Forfeiture
  • Jan 11, 2024
    FDA Holds Off on Calculating %DV of Nontraditional Sugars
  • Jan 10, 2024
    Florida Is the First State To Get FDA’s OK To Import Rx Drugs From Canada in Effort To Lower Prices
  • Jan 4, 2024
    OIG: Subsidies for Study Participants Covered by Medicare Would Not Pose Undue Risk of Fraud, Abuse
  • Jan 3, 2024
    CDRH Begins Issuing Export Documents in Electronic Form, Offers Online Authenticity Verification
  • Dec 27, 2023
    FDA Issues Guidance To Clarify Major Statement Final Rule
  • Dec 27, 2023
    Fischer Reintroduces Real MEAT Act in Senate
  • More

Medical Devices

  • Sep 1, 2021
    Online Tracker Provides Real-Time Information on FDA’s Progress in Reviewing Traditional 510(k)s
  • Aug 26, 2021
    FDA Tackles Need To Transition Some Drugs to Device Status in Compliance with D.C. Circuit Decision
  • Aug 19, 2021
    FDA Asks for Input on Role of Product Servicing in Strengthening Medical Device Cybersecurity
  • Aug 18, 2021
    District Court Rejects Relator’s Allegations That Device Maker Fraudulently Induced FDA Approval
  • Aug 3, 2021
    FDA’s Medical Device User Fee Increases Moderate for FY 2022; PMA, 510(k) Fees To Rise by 2.5%
  • Aug 2, 2021
    After Six Years, FDA Finalizes Rule on the Evidence Used To Determine the Intended Uses of Devices
  • Jul 28, 2021
    Woodcock Reports on Innovation in Device Emergency Use Authorization Reviews During Pandemic
  • Jul 22, 2021
    FDA Pushes for New Authorities, More Funding To Prevent Device Shortages, Strengthen Supply Chain
  • Jul 21, 2021
    St. Jude Medical To Pay $27 Million To Settle False Claims Allegations Linked to Faulty Heart Devices
  • Jul 15, 2021
    Alere To Pay $38.75 Million To Resolve Allegations That It Knowingly Sold Defective Blood Monitors
  • More

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