§ 356. Fast track products
(a)
Designation of drug as fast track product
(1)
In general
The Secretary shall, at the request of the sponsor of a new drug, facilitate the development and expedite the review of such drug if it is intended for the treatment of a serious or life-threatening condition and it demonstrates the potential to address unmet medical needs for such a condition. (In this section, such a drug is referred to as a “fast track product”.)
(2)
Request for designation
The sponsor of a new drug may request the Secretary to designate the drug as a fast track product. A request for the designation may be made concurrently with, or at any time after, submission of an application for the investigation of the drug under section
355
(i) of this title or section
262
(a)(3) of title
42.
(3)
Designation
Within 60 calendar days after the receipt of a request under paragraph (2), the Secretary shall determine whether the drug that is the subject of the request meets the criteria described in paragraph (1). If the Secretary finds that the drug meets the criteria, the Secretary shall designate the drug as a fast track product and shall take such actions as are appropriate to expedite the development and review of the application for approval of such product.
(b)
Approval of application for fast track product
(2)
Limitation
Approval of a fast track product under this subsection may be subject to the requirements—
(3)
Expedited withdrawal of approval
The Secretary may withdraw approval of a fast track product using expedited procedures (as prescribed by the Secretary in regulations which shall include an opportunity for an informal hearing) if—
(A)
the sponsor fails to conduct any required post-approval study of the fast track drug with due diligence;
(B)
a post-approval study of the fast track product fails to verify clinical benefit of the product;
(c)
Review of incomplete applications for approval of fast track product
(1)
In general
If the Secretary determines, after preliminary evaluation of clinical data submitted by the sponsor, that a fast track product may be effective, the Secretary shall evaluate for filing, and may commence review of portions of, an application for the approval of the product before the sponsor submits a complete application. The Secretary shall commence such review only if the applicant—
(2)
Exception
Any time period for review of human drug applications that has been agreed to by the Secretary and that has been set forth in goals identified in letters of the Secretary (relating to the use of fees collected under section
379h of this title to expedite the drug development process and the review of human drug applications) shall not apply to an application submitted under paragraph (1) until the date on which the application is complete.
(d)
Awareness efforts
The Secretary shall—