§505 (BLA)?

Center for Drug Evaluation & Research is considering whether to seek legislative action to change the approval process for biologics. The current BLA process "can't change until there's a legislative action, and whether we're going to seek that is really a question," CDER Deputy Director Steven Galson, MD, said at a Lehman Brothers healthcare conference in Miami March 5. "It's going to be more of a challenge for us to have both of the sets for procedures for BLAs and NDAs in our system," Galson said. "We've got working groups focusing on that problem, whether it makes sense to change it." Galson also echoed Commissioner McClellan's comments on generic biologics, saying, "the future holds generic biologics....When that future is, is really unclear"...