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Home » Newsletters » FDAnews Drug Weekly

FDAnews Drug Weekly Sign Up Now

June 5, 2023

View Archived Issues

FDA Approves Lynparza Combination for Certain Metastatic Prostate Cancer

Approval was based on phase 3 trial results that showed improvement in progression-free and overall survival. Read More

Upcoming Events

  • 06Jun

    Gene & Cell Therapy Regulation: Comparability and Other New Developments

  • 07Jun

    Developing World-Class SOPs: Optimizing Quality and Compliance

  • 08Jun

    Implementing ICH E8 R1 Recommendations Increases Site and Participant Relationship Scoring Measures

  • 13Jun

    Winners Only: 3 Steps to Compete in Digital Quality

  • 14Jun

    Pharmaceutical Quality Risk Management and ICH Q9(R1): Navigating the Global Intersection of Principle and Regulation

  • 20Jun

    What’s CSA? And how can it streamline your GxP System Verification?

Featured Products

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    FDA’s New Quality System Regulation: Transitioning from QSR to ISO 13485

  • Selecting and Implementing Electronic Document Management Systems in the EU

    Selecting and Implementing Electronic Document Management Systems in the EU

Featured Stories

  • FDA Approves Lynparza Combination for Certain Metastatic Prostate Cancer

  • Ezra Sees 510(k) Clearance for Ezra Flash AI Product for Faster, Better MRI Images

  • FDA Denies Akebia’s Vadadustat Appeal but Suggests a Path Forward

  • FDA Seeks Comments on Greater Access to Medical Technologies at Home

The Revised ICH E8: A Guide to New Clinical Trial Requirements

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