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Co-Authored-By: Claude Opus 4.8 <noreply@anthropic.com>
2026-07-06 10:51:44 -04:00

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LegalText 21 U.S.C. § 379d2 Policy on the review and clearance of scientific articles published by FDA employees us united_states_code code_section 21 FOOD AND DRUGS 9 FEDERAL FOOD, DRUG, AND COSMETIC ACT 379d2 21 U.S.C. § 379d2 current 119-100 2026-06-26 official https://uscode.house.gov/download/releasepoints/us/pl/119/100/xml_usc21@119-100.zip /us/usc/t21/s379d2 data/legal/raw/us/code/title-21/usc21.xml 55ede25d2e88f59a56bd95ad7d9caa44fb73f5b05b483140b97dadb9d12197bf 3dbd7a61c8616baefb8459bd8dac3b93242106deb416308c8d4dd5a9143176d1 c9a02edca3d33862945180b952f3df11982dd066029d63a1747b40c12afc7eee 2026-07-04 official
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21 U.S.C. § 379d2 - Policy on the review and clearance of scientific articles published by FDA employees

Text

(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.

(June 25, 1938, ch. 675, § 713, as added Pub. L. 11085, title XI, § 1101, Sept. 27, 2007, 121 Stat. 971.)