Great unknowns

PDUFA reauthorization passed a major milestone last week when the U.S. Senate's expert committee voted 15-5 in favor of a bill that extends drug and device user fees for five years and revamps drug safety oversight. But the final shape and impact of the legislation is still not clear.

PDUFA IV and associated legislation will certainly move the U.S. into an era of total lifecycle regulation for prescription drugs, and newly inserted provisions promise to increase the transparency of FDA deliberations. ...