Former FDA Chairman Robert Califf, M.D., stepped down on Jan. 20, 2017, and it’s not always easy to predict what the Center for Drug Evaluation and Research (CDER), or any FDA agency, will accomplish under a new chairman. Efforts at quality management could be affected by what appears to be an aggressive guidance agenda for 2017 from the CDER.

Many rumored candidates seem to indicate that they would reign in the FDA in significant ways. The CDER’s guidance agenda and other activities, including inspections, could be affected. On the other hand, any perceived threat to consumers, such as a serious drug recall, could always force the FDA and CDER to step up pharmaceutical manufacturer enforcement activities.

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