Title 21, Food and DrugsRelease 119-110

§379d–2 Policy on the Review and Clearance of Scientific Articles Published by Fda Employees

Title 21 › CHAPTER 9 — FEDERAL FOOD, DRUG, AND COSMETIC ACT › SUBCHAPTER VII — GENERAL AUTHORITY › Part A — General Administrative Provisions › § 379d–2

Last updated Sep 22, 2026|Official source

Summary

Requires the Secretary, through the FDA Commissioner, to write and publish clear rules about how FDA employees must send scientific writings (papers, posters, abstracts, book parts, or similar work) for review and what disclaimers to use. Employees must send a work at least 30 days before trying to publish or present it. Reviewers have 30 days to give written approval or require changes. If no written clearance by day 31, the employee may publish or present with the required disclaimer. Other laws that limit publication still apply.

Full Legal Text

Title 21, §379d–2

Food and Drugs, Source: USLM XML via OLRC

(a)Definition

In this section, the term “article” means a paper, poster, abstract, book, book chapter, or other published writing.

(b)Policies

The Secretary, through the Commissioner of Food and Drugs, shall establish and make publicly available clear written policies to implement this section and govern the timely submission, review, clearance, and disclaimer requirements for articles.

(c)Timing of submission for review

If an officer or employee, including a Staff Fellow and a contractor who performs staff work, of the Food and Drug Administration is directed by the policies established under subsection (b) to submit an article to the supervisor of such officer or employee, or to some other official of the Food and Drug Administration, for review and clearance before such officer or employee may seek to publish or present such an article at a conference, such officer or employee shall submit such article for such review and clearance not less than 30 days before submitting the article for publication or presentation.

(d)Timing for review and clearance

The supervisor or other reviewing official shall review such article and provide written clearance, or written clearance on the condition of specified changes being made, to such officer or employee not later than 30 days after such officer or employee submitted such article for review.

(e)Non-timely review

If, 31 days after such submission under subsection (c), the supervisor or other reviewing official has not cleared or has not reviewed such article and provided written clearance, such officer or employee may consider such article not to have been cleared and may submit the article for publication or presentation with an appropriate disclaimer as specified in the policies established under subsection (b).

(f)Effect

Nothing in this section shall be construed as affecting any restrictions on such publication or presentation provided by other provisions of law.

Reference

Citations & Metadata

Citation

21 U.S.C. § 379d–2

Title 21, Food and Drugs

Last Updated

Sep 22, 2026

Release point: 119-110