### Question
What does genetically targeted drug mean?


### Answer
**Genetically targeted drug** has the following meaning in *21 U.S.C. § 360ff*:

> a drug that—


(A) is the subject of an application under section 355(b)(1) of this title or section 351(a) of the Public Health Service Act [42 U.S.C. 262(a)] for the treatment of a rare disease or condition (as such term is defined in section 360bb of this title) that is serious or life-threatening

#### 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**

