FDA Extends Review Timeline For STELARA(TM) (ustekinumab) Biologic License Application By Three Months (Medical News Today)
Centocor Ortho Biotech Inc. announced that the U.S. Food and Drug Administration (FDA) has extended by three months the review timeline for the Biologic License Application (BLA) for STELARA(TM) (ustekinumab) to provide time for a full review of an amendment to the pending application.

FDA Officials Discuss Overhauling Agency In NEJM Perspective (Medical News Today)
"The FDA as a Public Health Agency," New England Journal of Medicine: In the perspective, FDA Commissioner Margaret Hamburg and Joshua Sharfstein, principal deputy commissioner of the agency, provide "a broad overview" of how they plan to "embrace" the agency's mission to protect the public's health. Hamburg and Sharfstein discuss their plans to work with other U.S.