> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Regulations Prevent Petition Response: FDA
- URL: https://www.fdaweb.com/regulations-prevent-petition-response-fda/
- Published: 2016-08-31T12:00:00.000Z
- Updated: 2026-09-14T21:28:34.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136667

FDA says that regulations generally prevent it from disclosing the existence of an IND or discussing much of the information in an IND file before the product is licensed. Thus, it [says](https://www.regulations.gov/contentStreamer?documentId=FDA-2016-P-0214-0008&attachmentNumber=1&disposition=attachment&contentType=pdf&ref=fdaweb.com), it can’t respond substantively to a Rosalind Advisors 1/16 citizen petition asking that it place the extracorporeal liver assist device being developed by Vital Therapies on clinical hold due to its treatment emergent adverse effect profile. The petition also said that Vital Therapies’ proposed Phase 3 trial is not adequate and well controlled, and expressed concern that FDA staff could harbor biases that may affect their judgment about the ethics of proceeding with the trial.

“If there were to be such a product as you describe under IND,” the letter says, “we assure you that we would consider the information you submitted and take appropriate actions based on the regulations governing clinical trials.”

The letter also says that FDA strictly follows ethics laws and regulations to promote and strengthen the public’s confidence in federal government integrity. It says that agency employees are generally prohibited from having a financial interest in a significantly regulated organization. Also, it says, regulatory decisions are typically reviewed by staff at multiple organizational levels.