21 U.S.C. § 356 : US Code - Section 356: Fast track products

Search 21 U.S.C. § 356 : US Code - Section 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
(1) In general
The Secretary may approve an application for approval of a fast
track product under section 355(c) of this title or section 262
of title 42 upon a determination that the product has an effect
on a clinical endpoint or on a surrogate endpoint that is
reasonably likely to predict clinical benefit.
(2) Limitation
Approval of a fast track product under this subsection may be
subject to the requirements -
(A) that the sponsor conduct appropriate post-approval
studies to validate the surrogate endpoint or otherwise confirm
the effect on the clinical endpoint; and
(B) that the sponsor submit copies of all promotional
materials related to the fast track product during the
preapproval review period and, following approval and for such
period thereafter as the Secretary determines to be
appropriate, at least 30 days prior to dissemination of the
materials.
(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) other evidence demonstrates that the fast track product
is not safe or effective under the conditions of use; or
(D) the sponsor disseminates false or misleading promotional
materials with respect to 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 -
(A) provides a schedule for submission of information
necessary to make the application complete; and
(B) pays any fee that may be required under section 379h of
this title.
(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 -
(1) develop and disseminate to physicians, patient
organizations, pharmaceutical and biotechnology companies, and
other appropriate persons a description of the provisions of this
section applicable to fast track products; and
(2) establish a program to encourage the development of
surrogate endpoints that are reasonably likely to predict
clinical benefit for serious or life-threatening conditions for
which there exist significant unmet medical needs.