Serious Adverse Event

Serious Adverse Event. Any serious and unexpected adverse drug experience, as defined by FDA in 21 C.F.R. Section 314.80 or Section 312.32, associated with the use of a Product in humans, whether or not considered drug-related.

Serious Adverse Event. Shall mean a product complaint of a serious or life threatening nature, the need for, results of or information relating to a recall, withdrawal, warning, inspection, hold, or other regulatory action or which is related to or could reasonably affect the OptiNose application or approval or the manufacture of the API or Finished Product hereunder.