IoM Report On Postmarketing Study Ethics Could Drive Broad Overhaul Of Informed Consent
• By The Pink Sheet Daily
Released in advance of Avandia advisory committee meeting, Institute of Medicine report provides a "conceptual framework" for deciding whether safety studies such as TIDE are ethical.
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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