### Question
How is the "clinical testing" defined?


### Answer
The term **clinical testing** is defined in *26 U.S.C. § 45C* as follows -

> any human clinical testing—


(i) which is carried out under an exemption for a drug being tested for a rare disease or condition under section 505(i) of the Federal Food, Drug, and Cosmetic Act (or regulations issued under such section),


(ii) which occurs—


(I) after the date such drug is designated under section 526 of such Act, and


(II) before the date on which an application with respect to such drug is approved under section 505(b) of such Act or, if the drug is a biological product, before the date on which a license for such drug is issued under section 351 of the Public Health Service Act; [1](#45C_1_target) and


  

(iii) which is conducted by or on behalf of the taxpayer to whom the designation under such section 526 applies

#### Citation:
  - *26 U.S.C. § 45C*
  - Heading: **Subtitle A-Income Taxes > CHAPTER 1-NORMAL TAXES AND SURTAXES > Subchapter A-Determination of Tax Liability > PART IV-CREDITS AGAINST TAX > Subpart D-Business Related Credits**

