Draft guideline modernizes EMA recommendations on quality of inhaled, nasal products
AgencyIQ Blog » FDA Today
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2d ago
Draft guideline modernizes EMA recommendations on quality of inhaled, nasal products ..read more
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FDA advisors endorse minimal residual disease (MRD) as accelerated approval endpoint for multiple myeloma
AgencyIQ Blog » FDA Today
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2d ago
FDA advisors endorse minimal residual disease (MRD) as accelerated approval endpoint for multiple myeloma ..read more
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How a failed ALS drug provides a blueprint for the FDA to create a ‘Conditional Withdrawal’ pathway
AgencyIQ Blog » FDA Today
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2d ago
How a failed ALS drug provides a blueprint for the FDA to create a ‘Conditional Withdrawal’ pathway ..read more
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To combat antimicrobial resistance, the FDA needs a reset
AgencyIQ Blog » FDA Today
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2d ago
To combat antimicrobial resistance, the FDA needs a reset ..read more
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FDA’s oncology advisory committee to consider MRD as a multiple myeloma endpoint
AgencyIQ Blog » FDA Today
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2w 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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2w 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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2w 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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2w 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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2w 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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2w ago
Accelerated Removal: FDA making use of new authority to withdraw ineffective drugs more quickly ..read more
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