News

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10-to-1: HHS solicits comments on regulations to eliminate under Trump EO
The US Department of Health and Human Services (HHS) and the US Food and Drug Administration (FDA) are seeking public input on regulations, rules, or guidelines that should be eliminated under ...
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FDA Adopts ICH Good Clinical Practice Addendum
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FDA explains when device 'servicing' becomes 'remanufacturing'
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FDA launches global Generic Drug Cluster
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FDA calls for input on peptide evaluation
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European Commission tightens requirements for duplicate MAAs
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EMA offers labeling flexibilities for COVID therapeutics
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Planning for a clinical trial application
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EMA plots earlier engagement with patient groups
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OPDP warns AcelRx over Dsuvia promotional materials
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Woodcock takes charge as acting FDA commissioner
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Cyberattack: EMA says leaked documents ‘manipulated’
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