21 U.S.C. § 356k Platform Technologies

• Library: United States Statutes
• Edition: prefLabel,label,title,shortLabel
• Currency: Current through P.L. 118-19 (published on www.congress.gov on 10/06/2023)
• Citation: 21 U.S.C. § 356k

(a) In general

The Secretary shall establish a program for the designation of platform technologies that meet the criteria described in subsection (b).

(b) Criteria

A platform technology incorporated within or utilized by a drug or biological product is eligible for designation as a designated platform technology under this section if-

(1) the platform technology is incorporated in, or utilized by, a drug approved under section 355 of this title or a biological product licensed under section 351 of the Public Health Service Act [ 42 U.S.C. 262 ];

(2) preliminary evidence submitted by the sponsor of the approved or licensed drug described in paragraph (1), or a sponsor that has been granted a right of reference to data submitted in the application for such drug, demonstrates that the platform technology has the potential to be incorporated in, or utilized by, more than one drug without an adverse effect on quality, manufacturing, or safety; and

(3) data or information submitted by the applicable person under paragraph (2) indicates that incorporation or utilization of the platform technology has a reasonable likelihood to bring significant efficiencies to the drug development or manufacturing process and to the review process.

(c) Request for designation

A person may request the Secretary designate a platform technology as a designated platform technology concurrently with, or at any time after, submission under section 355(i) of this title or section 351(a)(3) of the Public Health Service Act [ 42 U.S.C. 262(a)(3) ] for the investigation of a drug that incorporates or utilizes the platform technology that is the subject of the request.

(d) Designation

(1) In general

Not later than 90 calendar days after the receipt of a request under subsection (c), the Secretary shall determine whether the platform technology that is the subject of the request meets the criteria described in subsection (b).

(2) Designation

If the Secretary determines that the platform technology meets the criteria described in subsection (b), the Secretary shall designate the platform technology as a designated platform technology and may expedite the development and review of any subsequent application submitted under section 355(b) of this title or section 351(a) of the Public Health Service Act [ 42 U.S.C. 262(a) ] for a drug that uses or incorporates the platform technology pursuant to subsection (e), as appropriate.

(3) Determination not to designate