Agency pledges focus on post-market safety info

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The FDA says drug safety improvements at the agency will focus on the quality of post-market safety information received, new analytical tools and approaches for evaluating this information, and effective public communication about emerging risks—according to a speech by deputy commissioner for medical and scientific affairs Scott Gottlieb.

In what many saw as window dressing for his agency's response to the Democratic-controlled congressional oversight, Gottlieb said the new initiatives address several key areas highlighted in a recent report by the Institutes of Medicine and they should be seen as the agency making drug safety a top priority.

He said that FDA officials will seek new funding from the re-authorization of the Prescription Drug User Fee Act to gain access to more post-market database resources and other post-marketing surveillance activities.

Improving risk communication will require better tools, and more consistent approaches, Gottlieb said. “We will be developing guidance that will spell out how sponsors can rigorously evaluate their drug names, in a scientific fashion, to objectively measure whether they might present confusion.”

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