### Question
How does DRUGS AND DEVICES define qualified infectious disease product?


### Answer
Under *21 U.S.C. § 355f*, **qualified infectious disease product** is defined as:

> an antibacterial or antifungal drug for human use intended to treat serious or life-threatening infections, including those caused by—


(1) an antibacterial or antifungal resistant pathogen, including novel or emerging infectious pathogens

#### Citation:
  - *21 U.S.C. § 355f*
  - Heading: **CHAPTER 9-FEDERAL FOOD, DRUG, AND COSMETIC ACT > SUBCHAPTER V-DRUGS AND DEVICES > Part A-Drugs and Devices**

