### Question
What is the definition of serious adverse event report?


### Answer
The definition of **serious adverse event report** is as follows in *21 U.S.C. § 379aa*:

> 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**

