---
kind: "section"
citation: "21 U.S.C. § 355g"
title: "21"
title_heading: "Food and Drugs"
number: "355g"
heading: "Utilizing real world evidence"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/21/355g"
units:
  - "Chapter 9 — Federal Food, Drug, and Cosmetic Act"
  - "Subchapter V — Drugs and Devices"
  - "Part A — Drugs and Devices"
---

# §355g. Utilizing real world evidence

- (a) **In general—** The [Secretary](/usc/21/321.md?p=d) shall establish a program to evaluate the potential use of real world evidence—
  - (1) to help to support the approval of a new indication for a [drug](/usc/21/321.md?p=g-1) approved under [section 355(c) of this title](/usc/21/355.md?p=c); and
  - (2) to help to support or satisfy postapproval study requirements.
- (b) **Real world evidence defined—** In this section, the term “real world evidence” means data regarding the usage, or the potential benefits or risks, of a [drug](/usc/21/321.md?p=g-1) derived from sources other than traditional clinical trials.
- (c) **Program framework—**
  - (1) **In general—** Not later than 2 years after December 13, 2016, the [Secretary](/usc/21/321.md?p=d) shall establish a draft framework for implementation of the program under this section.
  - (2) **Contents of framework—** The framework shall include information describing—
    - (A) the sources of real world evidence, including ongoing safety surveillance, observational studies, registries, claims, and patient-centered outcomes research activities;
    - (B) the gaps in data collection activities;
    - (C) the standards and methodologies for collection and analysis of real world evidence; and
    - (D) the priority areas, remaining challenges, and potential pilot opportunities that the program established under this section will address.
  - (3) **Consultation—**
    - (A) **In general—** In developing the program framework under this subsection, the [Secretary](/usc/21/321.md?p=d) shall consult with regulated industry, academia, medical professional organizations, representatives of patient advocacy organizations, consumer organizations, disease research foundations, and other interested parties.
    - (B) **Process—** The consultation under [subparagraph (A)](#c-3-A) may be carried out through approaches such as—
      - (i) a public-private partnership with the entities described in such subparagraph in which the [Secretary](/usc/21/321.md?p=d) may participate;
      - (ii) a contract, grant, or other arrangement, as the [Secretary](/usc/21/321.md?p=d) determines appropriate, with such a partnership or an independent research organization; or
      - (iii) public workshops with the entities described in such subparagraph.
- (d) **Program implementation—** The [Secretary](/usc/21/321.md?p=d) shall, not later than 3 years after December 13, 2016, and in accordance with the framework established under [subsection (c)](#c), implement the program to evaluate the potential use of real world evidence.
- (e) **Guidance for industry—** The [Secretary](/usc/21/321.md?p=d) shall—
  - (1) utilize the program established under [subsection (a)](#a), its activities, and any subsequent pilots or written reports, to inform a guidance for industry on—
    - (A) the circumstances under which [sponsors](/usc/21/360fff.md?p=8) of [drugs](/usc/21/321.md?p=g-1) and the [Secretary](/usc/21/321.md?p=d) may rely on real world evidence for the purposes described in paragraphs [(1)](#a-1) and [(2)](#a-2) of subsection (a); and
    - (B) the appropriate standards and methodologies for collection and analysis of real world evidence submitted for such purposes;
  - (2) not later than 5 years after December 13, 2016, issue draft guidance for industry as described in [paragraph (1)](#e-1); and
  - (3) not later than 18 months after the close of the public comment period for the draft guidance described in [paragraph (2)](#e-2), issue revised draft guidance or final guidance.
- (f) **Rule of construction—**
  - (1) **In general—** Subject to [paragraph (2)](#f-2), nothing in this section prohibits the [Secretary](/usc/21/321.md?p=d) from using real world evidence for purposes not specified in this section, provided the [Secretary](/usc/21/321.md?p=d) determines that sufficient basis exists for any such nonspecified use.
  - (2) **Standards of evidence and Secretary’s authority—** This section shall not be construed to alter—
    - (A) the standards of evidence under—
      - (i) subsection (c) or (d) of [section 355 of this title](/usc/21/355.md), including the substantial evidence standard in such [subsection (d)](#d); or
      - (ii) [section 262(a) of title 42](/usc/42/262.md?p=a); or
    - (B) the [Secretary](/usc/21/321.md?p=d)’s authority to require postapproval studies or clinical trials, or the standards of evidence under which studies or trials are evaluated.

## Source credit

(June 25, 1938, ch. 675, § 505F, as added Pub. L. 114–255, div. A, title III, § 3022, Dec. 13, 2016, 130 Stat. 1096; amended Pub. L. 115–52, title IX, § 901(c), (d), Aug. 18, 2017, 131 Stat. 1076.)

## Notes

### Editorial Notes

### Amendments

2017—Subsec. (b). Pub. L. 115–52, § 901(c), substituted “traditional” for “randomized”.

Subsec. (d). Pub. L. 115–52, § 901(d), substituted “3 years” for “2 years”.