### Question
How is the "serious adverse event report" defined?


### Answer
The term **serious adverse event report** is defined in *21 U.S.C. § 379aa* as follows -

> a report that is required to be submitted to the Secretary under subsection (b)

#### Citation:
  - *21 U.S.C. § 379aa*
  - Heading: **CHAPTER 9-FEDERAL FOOD, DRUG, AND COSMETIC ACT > SUBCHAPTER VII-GENERAL AUTHORITY > Part H-Serious Adverse Event Reports**

