“BioShield” Law Nears Passage; FDA Proposes “Pre-Pre-IND” Meetings
Executive Summary
FDA counterterrorism regulations will likely face added scrutiny following the expected enactment of Project BioShield, which allows for wider use of investigational products in emergency situations
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FDA Emergency Use Authorization For Bioterror Drugs Includes HHS Consultation
FDA will consult with an HHS panel when making decisions on which drug candidates could be authorized for emergency use
FDA Emergency Use Authorization For Bioterror Drugs Includes HHS Consultation
FDA will consult with an HHS panel when making decisions on which drug candidates could be authorized for emergency use