FDA, Industry: Agency Response To Ebola Is Not Replicable For All Rare Diseases

FDA's top official and a key biotechnology trade group official warned that the agency's flexible policies surrounding the Ebola response, including allowing the early use of investigative therapies, might not be applicable in all cases of rare diseases. FDA Commissioner Margaret Hamburg also said this week that it is unlikely Ebola vaccines in development would receive orphan drug designation since they would be administered to a broad population, but touted the agency's recent efforts to accelerate access to investigative new...