
From the U.S. Code Online via GPO Access
[wais.access.gpo.gov]
[Laws in effect as of January 2, 2001]
[Document not affected by Public Laws enacted between
  January 2, 2001 and January 28, 2002]
[CITE: 21USC356]

 
                        TITLE 21--FOOD AND DRUGS
 
             CHAPTER 9--FEDERAL FOOD, DRUG, AND COSMETIC ACT
 
                     SUBCHAPTER V--DRUGS AND DEVICES
 
                        Part A--Drugs and Devices
 
Sec. 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.

(June 25, 1938, ch. 675, Sec. 506, as added Pub. L. 105-115, title I, 
Sec. 112(a), Nov. 21, 1997, 111 Stat. 2309.)


                            Prior Provisions

    A prior section 356, act June 25, 1938, ch. 675, Sec. 506, as added 
Dec. 22, 1941, ch. 613, Sec. 3, 55 Stat. 851; amended Pub. L. 102-300, 
Sec. 6(b)(2), June 16, 1992, 106 Stat. 240; Pub. L. 103-80, Sec. 3(o), 
Aug. 13, 1993, 107 Stat. 777, related to certification of drugs 
containing insulin, prior to repeal by Pub. L. 105-115, title I, 
Sec. 125(a)(1), Nov. 21, 1997, 111 Stat. 2325.


                             Effective Date

    Section effective 90 days after Nov. 21, 1997, except as otherwise 
provided, see section 501 of Pub. L. 105-115, set out as an Effective 
Date of 1997 Amendment note under section 321 of this title.


                                Guidance

    Section 112(b) of Pub. L. 105-115 provided that: ``Within 1 year 
after the date of enactment of this Act [Nov. 21, 1997], the Secretary 
of Health and Human Services shall issue guidance for fast track 
products (as defined in section 506(a)(1) of the Federal Food, Drug, and 
Cosmetic Act [21 U.S.C. 356(a)(1)]) that describes the policies and 
procedures that pertain to section 506 of such Act.''

                  Section Referred to in Other Sections

    This section is referred to in title 15 section 1459; title 42 
section 1396r-8.
