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Title 21 — Food and DrugsRelease 119-73not60

§356b Reports of Postmarketing Studies

Title 21 › Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part A— Drugs and Devices › § 356b

Last updated Apr 5, 2026|Official source

Summary

Sponsors who agree with the Secretary to run a postmarketing study must send a progress report within 1 year after the drug is approved and then every year until the study is finished or stopped. The report must follow the form the Secretary sets in regulations. For drugs approved under accelerated approval, sponsors must report on any study required under section 356(c) no later than 180 days after approval and at least every 180 days after that, including enrollment, milestones, and other items the Secretary requires. The FDA must quickly publish that information on its website in a searchable way. Agreements made before November 21, 1997 follow the 1-year rule, and an initial report for those must be filed within 6 months after the Secretary issues the regulations. Report information that identifies the sponsor and shows the study’s status or reasons for not doing the study is public. The Secretary must publish an annual status report in the Federal Register about agreed postmarketing studies and those with submitted reports. If a sponsor misses a deadline, the Secretary must post on the FDA website that the study was not completed and, if the reasons are unsatisfactory, say so. For certain studies named in section 356(c)(2)(A) or in sections 314.510 or 601.41 of title 21 of the Code of Federal Regulations as they were the day before this subsection took effect, the Secretary may require sponsors who missed deadlines for unacceptable reasons to tell prescribing doctors about the unfinished study and any unanswered questions about benefit or, when appropriate, safety. Nothing here changes those study rules or stops the Secretary from adding more.

Full Legal Text

Title 21, §356b

Food and Drugs — Source: USLM XML via OLRC

(a)(1)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.
(2)Notwithstanding 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 section 356(c) of this title, 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.
(3)Any agreement entered into between the Secretary and a sponsor of a drug, prior to November 21, 1997, 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).
(b)Any information pertaining to a report described in subsection (a) shall be considered to be public information to the extent that the information is necessary—
(1)to identify the sponsor; and
(2)to establish the status of a study described in subsection (a) and the reasons, if any, for any failure to carry out the study.
(c)The Secretary shall annually develop and publish in the Federal Register a report that provides information on the status of the postmarketing studies—
(1)that sponsors have entered into agreements to conduct; and
(2)for which reports have been submitted under subsection (a)(1).
(d)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.
(e)With respect to studies of the type required under section 356(c)(2)(A) of this title 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 section 356(c)(2)(A) of this title 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.

Legislative History

Notes & Related Subsidiaries

Editorial Notes

References in Text

The

Effective Date

of this subsection, referred to in subsec. (e), is Oct. 1, 2002, see

Effective Date

of 2002 Amendment note set out below.

Amendments

2022—Subsec. (a)(2), (3). Pub. L. 117–328 added par. (2) and redesignated former par. (2) as (3). 2012—Subsec. (e). Pub. L. 112–144 substituted “section 356(c)(2)(A) of this title” for “section 356(b)(2)(A) of this title” in two places. 2002—Subsecs. (d), (e). Pub. L. 107–188 added subsecs. (d) and (e).

Statutory Notes and Related Subsidiaries

Effective Date

of 2002 Amendment Pub. L. 107–188, title V, § 508, June 12, 2002, 116 Stat. 694, provided that: “The

Amendments

made by this subtitle [subtitle A (§§ 501–509) of title V of Pub. L. 107–188, amending this section and section 379g and 379h of this title] shall take effect October 1, 2002.”

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.

Construction

of 2022 AmendmentNothing in amendment made by Pub. L. 117–328 to be construed to affect ongoing withdrawal proceedings for products approved pursuant to section 356(c) of this title for which a notice of proposed withdrawal has been published in the Federal Register prior to Dec. 29, 2022, see section 3210(f) of Pub. L. 117–328, set out as a note under section 356 of this title. Report to Congressional Committees Pub. L. 105–115, title I, § 130(b), Nov. 21, 1997, 111 Stat. 2331, provided that not later than Oct. 1, 2001, the Secretary was to submit to Congress a report containing a summary of the reports submitted under section 356b of this title and an evaluation and legislative recommendations relating to postmarketing studies of drugs.

Reference

Citations & Metadata

Citation

21 U.S.C. § 356b

Title 21 — Food and Drugs

Last Updated

Apr 5, 2026

Release point: 119-73not60