Drug safety- FDA concern about black box warning

[Guest guest]

Dear Members,

Agency reviews the data based on new information available related to drug and evaluates whether there is a potential drug safety concern.

When a potential drug safety concern arises, relevant scientific experts within the Agency engage in a prompt review and analysis of available data.

Often, there is a period of uncertainty while FDA evaluates the new safety information to determine whether there is an important drug safety issue related to a specific drug or drug class and whether regulatory action is appropriate. During this period, FDA also is actively engaged in scientific efforts to gather additional safety information.

Tarun Wadhwa