‘‘Subchapter J—Precision Medicine 
‘‘SEC. 591. GENERAL AGENCY GUIDANCE ON PRECISION 
MEDICINE. 
‘‘(a) IN GENERAL.—The Secretary shall issue and 
periodically update guidance to assist sponsors in the de-
velopment of a precision drug or biological product. Such 
guidance shall— 
‘‘(1) define the term ‘precision drug or biologi-
cal product’; and 
‘‘(2) address the topics described in subsection 
(b). 
‘‘(b) CERTAIN ISSUES.—The topics to be addressed 
by guidance under subsection (a) are— 
‘‘(1) the evidence needed to support the use of 
biomarkers (as defined in section 507(e)) that iden-
tify subsets of patients as likely responders to thera-
pies in order to streamline the conduct of clinical 
trials; 
‘‘(2) recommendations for the design of studies 
to demonstrate the validity of a biomarker as a pre-
dictor of drug or biological product response; 
‘‘(3) the manner and extent to which a benefit- 
risk assessment may be affected when clinical trials 
are limited to patient population subsets that are 
identified using biomarkers; 
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‘‘(4) the development of companion diagnostics 
in the context of a drug development program; and 
‘‘(5) considerations for developing biomarkers 
that aid prescribing decisions for a drug or biological 
product, and when information regarding a bio-
marker may be included in the labeling for a drug 
or biological product approved under section 505 of 
this Act or section 351 of the Public Health Service 
Act. 
‘‘(c) DATE CERTAIN FOR INITIAL GUIDANCE.—The 
Secretary shall issue guidance under subsection (a) not 
later than 18 months after the date of the enactment of 
the 21st Century Cures Act. 
‘‘SEC. 592. PRECISION MEDICINE REGARDING ORPHAN- 
DRUG 
AND 
EXPEDITED-APPROVAL 
PRO-
GRAMS. 
‘‘In the case of an application for a precision drug 
or biological product under section 505(b)(1), or section 
351(a) of the Public Health Service Act, that has been 
designated under section 526 as a drug for a rare disease 
for a serious condition, the Secretary may— 
‘‘(1) consistent with applicable standards for 
approval, rely upon data or information previously 
developed by the sponsor of the precision drug or bi-
ological product for a prior approved drug or indica-
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tion (or that of another sponsor, provided the spon-
sor of the precision drug or biological product has 
obtained a contractual right of reference to such 
other sponsor’s data and information) in order to ex-
pedite clinical development for a precision drug or 
indication that is using the same or similar approach 
as that of the prior approved drug or indication; and 
‘‘(2) as appropriate under section 506, consider 
the application for approval of such precision drug 
or biological product to be eligible for expedited re-
view, including under section 506(c) (relating to ac-
celerated approval).’’. 
Æ 
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