---
kind: "section"
citation: "21 U.S.C. § 356b"
title: "21"
title_heading: "Food and Drugs"
number: "356b"
heading: "Reports of postmarketing studies"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/21/356b"
units:
  - "Chapter 9 — Federal Food, Drug, and Cosmetic Act"
  - "Subchapter V — Drugs and Devices"
  - "Part A — Drugs and Devices"
---

# §356b. Reports of postmarketing studies

- (a) **Submission—**
  - (1) **In general—** A [sponsor](/usc/21/360fff.md?p=8) of a [drug](/usc/21/321.md?p=g-1) that has entered into an agreement with the [Secretary](/usc/21/321.md?p=d) to conduct a postmarketing study of a [drug](/usc/21/321.md?p=g-1) shall submit to the [Secretary](/usc/21/321.md?p=d), within 1 year after the approval of such [drug](/usc/21/321.md?p=g-1) 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](/usc/21/360fff.md?p=8) to conduct the study. The report shall be submitted in such form as is prescribed by the [Secretary](/usc/21/321.md?p=d) in regulations issued by the [Secretary](/usc/21/321.md?p=d).
  - (2) **Accelerated approval—** Notwithstanding [paragraph (1)](#a-1), a [sponsor](/usc/21/360fff.md?p=8) of a [drug](/usc/21/321.md?p=g-1) approved pursuant to accelerated approval shall submit to the [Secretary](/usc/21/321.md?p=d) a report of the progress of any study required under [section 356(c) of this title](/usc/21/356.md?p=c), including progress toward enrollment targets, milestones, and other information as required by the [Secretary](/usc/21/321.md?p=d), not later than 180 days after the approval of such [drug](/usc/21/321.md?p=g-1) and not less frequently than every 180 days thereafter, until the study is completed or terminated. The [Secretary](/usc/21/321.md?p=d) shall promptly publish on the website of the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration, in an easily searchable format, the information reported under this paragraph.
  - (3) **Agreements prior to effective date—** Any agreement entered into between the [Secretary](/usc/21/321.md?p=d) and a [sponsor](/usc/21/360fff.md?p=8) of a [drug](/usc/21/321.md?p=g-1), prior to November 21, 1997, to conduct a postmarketing study of a [drug](/usc/21/321.md?p=g-1) shall be subject to the requirements of [paragraph (1)](#a-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)](#a-1).
- (b) **Consideration of information as public information—** Any information pertaining to a report described in [subsection (a)](#a) shall be considered to be public information to the extent that the information is necessary—
  - (1) to identify the [sponsor](/usc/21/360fff.md?p=8); and
  - (2) to establish the status of a study described in [subsection (a)](#a) and the reasons, if any, for any failure to carry out the study.
- (c) **Status of studies and reports—** The [Secretary](/usc/21/321.md?p=d) shall annually develop and publish in the Federal Register a report that provides information on the status of the postmarketing studies—
  - (1) that [sponsors](/usc/21/360fff.md?p=8) have entered into agreements to conduct; and
  - (2) for which reports have been submitted under [subsection (a)(1)](#a-1).
- (d) **Disclosure—** If a [sponsor](/usc/21/360fff.md?p=8) fails to complete an agreed upon study required by this section by its original or otherwise negotiated deadline, the [Secretary](/usc/21/321.md?p=d) shall publish a statement on the Internet site of the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) 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](/usc/21/321.md?p=d), a statement that such reasons were not satisfactory to the [Secretary](/usc/21/321.md?p=d).
- (e) **Notification—** With respect to studies of the type required under [section 356(c)(2)(A) of this title](/usc/21/356.md?p=c-2-A) 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](/usc/21/321.md?p=d) may require that a [sponsor](/usc/21/360fff.md?p=8) who, for reasons not satisfactory to the [Secretary](/usc/21/321.md?p=d), fails to complete by its deadline a study under any of such sections of such type for a [drug](/usc/21/321.md?p=g-1) or biological [product](/usc/21/360eee.md?p=13) (including such a study conducted after such effective date) notify practitioners who prescribe such [drug](/usc/21/321.md?p=g-1) or biological [product](/usc/21/360eee.md?p=13) 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](/usc/21/356.md?p=c-2-A) or under section 314.510 or 601.41 of title 21, Code of Federal Regulations, as so in effect, or as prohibiting the [Secretary](/usc/21/321.md?p=d) from modifying such sections of [title 21](/usc/21.md) of such Code to provide for studies in addition to those of such type.

## Source credit

(June 25, 1938, ch. 675, § 506B, as added Pub. L. 105–115, title I, § 130(a), Nov. 21, 1997, 111 Stat. 2331; amended Pub. L. 107–188, title V, § 506, June 12, 2002, 116 Stat. 693; Pub. L. 112–144, title IX, § 902(c), July 9, 2012, 126 Stat. 1088; Pub. L. 117–328, div. FF, title III, § 3210(b), Dec. 29, 2022, 136 Stat. 5823.)

## Notes

### 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 sections 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 Amendment

Nothing 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.