Presynaptic Knob

Genetic analysis of an asymptomatic or unaffected individual who is at risk of a specific genetic disorder.

The state before the onset or development of clinical disease. Persons who have presymptomatic cancer already have developed the disease of cancer,…

Supplying or being a probable or reasonable settlement or result.

The status of an individual who in all likelihood is not living, but has not been officially declared dead.

A submission to the Agency that occurs prior to the actual submission of a full application, e.g., rolling review, reviewable unit, clinical…

Promotional materials intended to be used after the 120 day post-approval period that are submitted to FDA prior to dissemination/publication as required…