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Pharmaceuticals

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Posts in Category: Pharmaceuticals

  • Biosimilars Registration: SFDA Considerations

  • Economic-Evaluation-Studies-EES-SFDA

    How to write Economic Evaluation Studies (EES) for SFDA?

  • Overview of SFDA Conditional Approval for New Medicines

  • SFDA Drug Pricing Rules in Saudi Arabia

  • CAR-T-Cell-Registration-in-SFDA

    CAR T Cell Registration in SFDA

  • How to apply for breakthrough medicine designation

    Breakthrough Medicines Designation in SFDA

  • orphan drug in Saudi Arabia

    Orphan Drug Designation (ODD) in SFDA

  • Saudi Drug Information (SFDA SDI)

    Drug Information and Stock Reporting to SFDA (SDI)

  • SFDA recall procedure in Saudi Arabia

    Product Recall in Saudi Arabia

  • Medicinal gas registration in Saudi as a medical device

    Medical Gas Registration

  • Clinical trials CRO requirements

    SFDA Clinical Trials Requirements in Saudi Arabia

  • SFDA-Variation types in the guidelines

    SFDA Variation Guidelines (Version 6.3)

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