2016 US Code
Title 21 - Food and Drugs
Chapter 9 - Federal Food, Drug, and Cosmetic Act
Subchapter V - Drugs and Devices
Part A - Drugs and Devices
Sec. 360n-1 - Priority review for qualified infectious disease products
| 21 U.S.C. § 360n-1 (2016) |
| §360n–1. Priority review for qualified infectious disease products |
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(a) In general
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 the first application submitted for approval for such drug under section 355(b) of this title. (b) ConstructionNothing in this section shall prohibit the Secretary from giving priority review to a human drug application or efficacy supplement submitted for approval under section 355(b) of this title that otherwise meets the criteria for the Secretary to grant priority review. |
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(June 25, 1938, ch. 675, §524A, as added Pub. L. 112–144, title VIII, §802(a), July 9, 2012, 126 Stat. 1079; amended Pub. L. 114–255, div. A, title III, §3101(a)(2)(N), Dec. 13, 2016, 130 Stat. 1154.) |
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AMENDMENTS
2016—Pub. L. 114–255 designated existing provisions as subsec. (a), inserted heading, substituted "the first application" for "any application", and added subsec. (b). EFFECTIVE DATEPub. 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]." |
| United States Code, 2012 Edition, Supplement 4, Title 21 - FOOD AND DRUGS |
| Bills and Statutes |
| United States Code |
| Y 1.2/5: |
| Title 21 - FOOD AND DRUGS CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT SUBCHAPTER V - DRUGS AND DEVICES Part A - Drugs and Devices Sec. 360n-1 - Priority review for qualified infectious disease products |
| section 360n-1 |
| 2016 |
| January 6, 2017 |
| No |
| standard |
| 126 Stat. 1079 130 Stat. 1154 |
| Public Law 112-144, Public Law 114-255 |
