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Rules Eased on Access to Investigational Drugs (FDA)

— Full IRB approval no longer needed; companies can decide which adverse events to report

MedpageToday

The FDA is taking steps to encourage wider use of the agency's "Expanded Access" pathway that permits physicians to prescribe investigational drugs, according to a .

Until today it was necessary for physicians to obtain approval from an institutional review board (IRB) meeting in full, now they only have to gain assent from a single IRB member -- either the chairman "or another appropriate person," Gottlieb said.

Moreover companies developing novel drugs no longer have to report to the FDA all adverse events associated with expanded-access use; henceforth they are required to report such events "only if there is evidence to suggest a causal relationship between the drug and the adverse event."