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

Summary

The FDA must create and publish clear written rules about how its staff should submit, review, clear, and label scientific writings. An "article" means things like a paper, poster, abstract, book, book chapter, or other published writing. If the rules say an FDA worker (including a Staff Fellow or a contractor doing staff work) must send an article to a supervisor or other FDA official for review before trying to publish or present it, the worker must send it at least 30 days before they plan to submit it for publication or presentation. The reviewer must read the article and give a written OK, or a written OK that requires specific changes, within 30 days of getting it. If 31 days pass and the reviewer has not given written clearance, the worker may treat it as not cleared and may go ahead and submit the article with the required disclaimer the FDA rules specify. Other laws or rules that limit publication still apply.