21 U.S. Code § 360n–1 - Priority review for qualified infectious disease products

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If the Secretary designates a drug under section 355f(d) of this title as a qualified infectious disease product, then the Secretary shall give priority review to any application submitted for approval for such drug under section 355 (b) of this title.


(June 25, 1938, ch. 675, § 524A, as added Pub. L. 112–144, title VIII, § 802(a),July 9, 2012, 126 Stat. 1079.)
Effective Date

Pub. L. 112–144, title VIII, § 802(b),July 9, 2012, 126 Stat. 1079, provided that: “Section 524A of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360n–1], 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 [July 9, 2012].”

The table below lists the classification updates, since Jan. 3, 2012, for this section. Updates to a broader range of sections may be found at the update page for containing chapter, title, etc.

The most recent Classification Table update that we have noticed was Tuesday, August 13, 2013

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21 USCDescription of ChangeSession YearPublic LawStatutes at Large
§ 360n-1new2012112-144 [Sec.] 802(a) "524A"126 Stat. 1079
§ 360n-1nt new2012112-144 [Sec.] 802(b)126 Stat. 1079


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