FDA’s oncology advisory committee to consider MRD as a multiple myeloma endpoint
AgencyIQ Blog » FDA Today
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3d ago
FDA’s oncology advisory committee to consider MRD as a multiple myeloma endpoint ..read more
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What we expect European regulators to do in April 2024
AgencyIQ Blog » FDA Today
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3d ago
What we expect European regulators to do in April 2024 ..read more
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FDA updates set the stage for broader use of harmonized standards for safety reporting
AgencyIQ Blog » FDA Today
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3d ago
FDA updates set the stage for broader use of harmonized standards for safety reporting ..read more
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FDA flexes its new accelerated approval authorities, hoping to accelerate access to confirmatory data
AgencyIQ Blog » FDA Today
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3d ago
FDA flexes its new accelerated approval authorities, hoping to accelerate access to confirmatory data ..read more
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EMA extends scientific advice pilot for high-risk medical devices
AgencyIQ Blog » FDA Today
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3d ago
EMA extends scientific advice pilot for high-risk medical devices ..read more
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Accelerated Removal: FDA making use of new authority to withdraw ineffective drugs more quickly
AgencyIQ Blog » FDA Today
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3d ago
Accelerated Removal: FDA making use of new authority to withdraw ineffective drugs more quickly ..read more
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The vote is in: The European Parliament has adopted the compromise pharmaceutical legislation
AgencyIQ Blog » FDA Today
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3d ago
The vote is in: The European Parliament has adopted the compromise pharmaceutical legislation ..read more
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Draft guidance on potency assays for CGT products garners extensive stakeholder input
AgencyIQ Blog » FDA Today
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3d ago
Draft guidance on potency assays for CGT products garners extensive stakeholder input ..read more
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Beyond bridging: How the FDA is changing the way it looks at foreign clinical data and diversity
AgencyIQ Blog » FDA Today
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3d ago
Beyond bridging: How the FDA is changing the way it looks at foreign clinical data and diversity ..read more
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FDA drafts ‘select updates’ to guidance on medical device cybersecurity, addressing statutory requirements
AgencyIQ Blog » FDA Today
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3w ago
FDA drafts ‘select updates’ to guidance on medical device cybersecurity, addressing statutory requirements ..read more
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