### Question
How does the law define serious adverse event report?


### Answer
Under *21 U.S.C. § 379aa*, **serious adverse event report** is defined as:

> 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**

