{"identifier":"/us/usc/t21/s360n\u20131","title":21,"num":"\u00a7\u202f360n\u20131.","heading":"Priority review for qualified infectious disease products","text":"\u00a7\u202f360n\u20131.\nPriority review for qualified infectious disease products\n(a)\nIn general\nIf the Secretary designates a drug under\nsection 355f(d) of this title\nsection 355(b) of this title\nsection 262(a) of title 42\n(b)\nConstruction\nNothing in this section shall prohibit the Secretary from giving priority review to a human drug application or efficacy supplement submitted for approval under\nsection 355(b) of this title","url":"https://projectusc.org/usc/t21/s360n\u20131.html","content":[{"t":"sec","id":"/us/usc/t21/s360n\u20131","children":[{"t":"num","text":"\u00a7\u202f360n\u20131."},{"t":"heading","text":"Priority review for qualified infectious disease products"},{"t":"subsec","id":"/us/usc/t21/s360n\u20131/a","children":[{"t":"num","text":"(a)"},{"t":"heading","text":"In general"},{"t":"content","children":[{"t":"p","text":"If the Secretary designates a drug under ","children":[{"t":"ref","text":"section 355f(d) of this title","href":"/us/usc/t21/s355f/d","tail":" as a qualified infectious disease product, then the Secretary shall give priority review to the first application submitted for approval for such drug under "},{"t":"ref","text":"section 355(b) of this title","href":"/us/usc/t21/s355/b","tail":", or "},{"t":"ref","text":"section 262(a) of title 42","href":"/us/usc/t42/s262/a","tail":", that requires clinical data (other than bioavailability studies) to demonstrate safety or effectiveness."}],"tail":"\n"}],"tail":"\n"}],"tail":"\n"},{"t":"subsec","id":"/us/usc/t21/s360n\u20131/b","children":[{"t":"num","text":"(b)"},{"t":"heading","text":"Construction"},{"t":"content","children":[{"t":"p","text":"Nothing in this section shall prohibit the Secretary from giving priority review to a human drug application or efficacy supplement submitted for approval under ","children":[{"t":"ref","text":"section 355(b) of this title","href":"/us/usc/t21/s355/b","tail":" that otherwise meets the criteria for the Secretary to grant priority review."}],"tail":"\n"}],"tail":"\n"}],"tail":"\n"},{"t":"text","text":"\n"},{"t":"text","text":"\n"}]}]}