### Question
Can you define what rare pediatric disease product application means?


### Answer
**Rare pediatric disease product application** is defined as the following in *21 U.S.C. § 360ff*:

> a human drug application, as defined in section 379g(1) of this title, that—


(A) is for a drug or biological product that is for the prevention or treatment of a rare pediatric disease

#### Citation:
  - *21 U.S.C. § 360ff*
  - Heading: **CHAPTER 9-FEDERAL FOOD, DRUG, AND COSMETIC ACT > SUBCHAPTER V-DRUGS AND DEVICES > Part B-Drugs for Rare Diseases or Conditions**

