The Secretary may, at the request of an applicant of a drug that is designated as a competitive generic therapy pursuant to subsection (b), expedite the development and review of an abbreviated new drug application under section 355(j) of this title for such drug.
The applicant may request the Secretary to designate the drug as a competitive generic therapy.
A request under paragraph (1) may be made concurrently with, or at any time prior to, the submission of an abbreviated new drug application for the drug under section 355(j) of this title.
A drug is eligible for designation as a competitive generic therapy under this section if the Secretary determines that there is inadequate generic competition.
Not later than 60 calendar days after the receipt of a request under paragraph (1), the Secretary may-
In expediting the development and review of an application under subsection (a), the Secretary may, as requested by the applicant, take actions including the following:
Not later than one year after the date of the approval of an application under section 355(j) of this title with respect to a drug for which the development and review is expedited under this section, the sponsor of such drug shall report to the Secretary on whether the drug has been marketed in interstate commerce since the date of such approval.
In this section:
1So in original. Probably should be "drug".
21 U.S.C. § 356h
STATUTORY NOTES AND RELATED SUBSIDIARIES
GUIDANCE; AMENDED REGULATIONS Pub. L. 115-52, title VIII, §803(b), Aug. 18, 2017, 131 Stat. 1071, provided that:"(1) IN GENERAL.-"(A) ISSUANCE.-The Secretary of Health and Human Services shall-"(i) not later than 18 months after the date of enactment of this Act [Aug. 18, 2017], issue draft guidance on section 506H of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 356h], as added by subsection (a); and"(ii) not later than 1 year after the close of the comment period for the draft guidance, issue final guidance on such section 506H."(B) CONTENTS.-The guidance issued under this paragraph shall-"(i) specify the process and criteria by which the Secretary makes a designation under section 506H of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a);"(ii) specify the actions the Secretary may take to expedite the development and review of a competitive generic therapy pursuant to such a designation; and"(iii) include good review management practices for competitive generic therapies."(2) AMENDED REGULATIONS.-The Secretary of Health and Human Services shall issue or revise any regulations as may be necessary to carry out this section not later than 2 years after the date of enactment of this Act [Aug. 18, 2017]."