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Latest From Michael Cipriano
The latest drug development news and highlights from our US FDA Performance Tracker.
FDA recommends sponsors take the breakpoint information out of the labels for their approved antimicrobial products, and instead include a link to agency's newly launched website with breakpoint data.
Third-party contractor will conduct evaluation of agency's communications with sponsors throughout IND process as part of PDUFA VI commitments.
US FDA's first such guidance will focus on hemophilia, commissioner tells Congress.
The goal of monitoring Twitter and chat rooms is to proactively identify patterns of misuse and abuse before they fully manifest, Commissioner Gottlieb says.
Although study was meant to be critical of expedited pathways, it showed that drugs with at least one of the designations experience lower clinical development times.