Submission
In general
A sponsor of a drug that has entered into an agreement with the Secretary to conduct a postmarketing study of a drug shall submit to the Secretary, within 1 year after the approval of such drug and annually thereafter until the study is completed or terminated, a report of the progress of the study or the reasons for the failure of the sponsor to conduct the study. The report shall be submitted in such form as is prescribed by the Secretary in regulations issued by the Secretary.
Accelerated approval
section 356(c) of this titleNotwithstanding paragraph (1), a sponsor of a drug approved pursuant to accelerated approval shall submit to the Secretary a report of the progress of any study required under , including progress toward enrollment targets, milestones, and other information as required by the Secretary, not later than 180 days after the approval of such drug and not less frequently than every 180 days thereafter, until the study is completed or terminated. The Secretary shall promptly publish on the website of the Food and Drug Administration, in an easily searchable format, the information reported under this paragraph.
Agreements prior to effective date
Any agreement entered into between the Secretary and a sponsor of a drug, prior to , to conduct a postmarketing study of a drug shall be subject to the requirements of paragraph (1). An initial report for such an agreement shall be submitted within 6 months after the date of the issuance of the regulations under paragraph (1).
Consideration of information as public information
Status of studies and reports
Disclosure
If a sponsor fails to complete an agreed upon study required by this section by its original or otherwise negotiated deadline, the Secretary shall publish a statement on the Internet site of the Food and Drug Administration stating that the study was not completed and, if the reasons for such failure to complete the study were not satisfactory to the Secretary, a statement that such reasons were not satisfactory to the Secretary.
Notification
section 356(c)(2)(A) of this titlesection 356(c)(2)(A) of this titleWith respect to studies of the type required under or under section 314.510 or 601.41 of title 21, Code of Federal Regulations, as each of such sections was in effect on the day before the effective date of this subsection, the Secretary may require that a sponsor who, for reasons not satisfactory to the Secretary, fails to complete by its deadline a study under any of such sections of such type for a drug or biological product (including such a study conducted after such effective date) notify practitioners who prescribe such drug or biological product of the failure to complete such study and the questions of clinical benefit, and, where appropriate, questions of safety, that remain unanswered as a result of the failure to complete such study. Nothing in this subsection shall be construed as altering the requirements of the types of studies required under or under section 314.510 or 601.41 of title 21, Code of Federal Regulations, as so in effect, or as prohibiting the Secretary from modifying such sections of title 21 of such Code to provide for studies in addition to those of such type.
June 25, 1938, ch. 675, § 506BPub. L. 105–115, title I, § 130(a)111 Stat. 2331Pub. L. 107–188, title V, § 506116 Stat. 693Pub. L. 112–144, title IX, § 902(c)126 Stat. 1088Pub. L. 117–328, div. FF, title III, § 3210(b)136 Stat. 5823(, as added , , ; amended , , ; , , ; , , .)
Editorial Notes
References in Text
The effective date of this subsection, referred to in subsec. (e), is , see Effective Date of 2002 Amendment note set out below.
Amendments
Pub. L. 117–3282022—Subsec. (a)(2), (3). added par. (2) and redesignated former par. (2) as (3).
Pub. L. 112–144section 356(c)(2)(A) of this titlesection 356(b)(2)(A) of this title2012—Subsec. (e). substituted “” for “” in two places.
Pub. L. 107–1882002—Subsecs. (d), (e). added subsecs. (d) and (e).
Statutory Notes and Related Subsidiaries
Effective Date of 2002 Amendment
Pub. L. 107–188, title V, § 508116 Stat. 694
Effective Date
section 501 of Pub. L. 105–115section 321 of this titleSection effective 90 days after , except as otherwise provided, see , set out as an Effective Date of 1997 Amendment note under .
Construction of 2022 Amendment
Pub. L. 117–328section 356(c) of this titlesection 3210(f) of Pub. L. 117–328section 356 of this titleNothing in amendment made by to be construed to affect ongoing withdrawal proceedings for products approved pursuant to for which a notice of proposed withdrawal has been published in the Federal Register prior to , see , set out as a note under .
Report to Congressional Committees
Pub. L. 105–115, title I, § 130(b)111 Stat. 2331section 356b of this title, , , provided that not later than , the Secretary was to submit to Congress a report containing a summary of the reports submitted under and an evaluation and legislative recommendations relating to postmarketing studies of drugs.