Drug safety- FDA concern about black box warning

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Dear Members,

The Drug Safety Oversight Board may be consulted and provide recommendations to the Director of the Center for Drug Evaluation and Research regarding the management and communication of an emerging drug safety issue.

FDA also may consult an Advisory Committee regarding an emerging drug safety issue. Sponsors are also evaluating the new safety information and providing the results of their analyses to FDA during this time.

Tarun Wadhwa