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."