Drug safety- FDA concern about black box warning

[Guest guest]

Dear Members,

As additional data relevant to an emerging drug safety issue become available (e.g., data from an ongoing study or data from available clinical databases), such data are considered in the analysis and decision-making process.

Upon evaluation of additional data, further regulatory action, such as a revision to product labeling or a Risk Minimization Action Plan (RiskMAP), may be appropriate.

Tarun Wadhwa