Pub. L. 112-144, tit. VIII, sec. 802 (as amended)
PRIORITY REVIEW.
SEC. 802. PRIORITY REVIEW.
(a) Amendment.—Chapter V (21 U.S.C. 351 et seq.) is amended by inserting after section 524 the following:
“SEC. 524A. [21 U.S.C. 360n-1] PRIORITY REVIEW FOR QUALIFIED INFECTIOUS DISEASE PRODUCTS
“If the Secretary designates a drug under section 505E(d) as a qualified infectious disease product, then the Secretary shall give priority review to any application submitted for approval for such drug under section 505(b).”
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(b) [21 U.S.C. 360n-1 note] Application.—Section 524A of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a), applies only with respect to an application that is submitted under section 505(b) of such Act (21 U.S.C. 355(b)) on or after the date of the enactment of this Act.
- Cross-references to the US Code
- 21 U.S.C. 360n-121 U.S.C. 360n-1 note