Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

FDA citizen petition tentative replies should indicate agency position, IG says.

This article was originally published in The Tan Sheet

Executive Summary

FDA CITIZEN PETITION TENTATIVE REPLIES SHOULD INDICATE POSITION as to whether the petition will be granted or denied, the HHS Inspector General recommends in a report reviewing the FDA citizen petition process. The report recommends the agency "include in all tentative responses to petitioners an estimate of when a final response will be issued and, to the extent possible, a preliminary indication of whether FDA will approve or deny the petition." The report was issued July 17.

You may also be interested in...



Citizen Petition Preemption Of FDA Action Barred Under Proposed Rule

Pending FDA actions cannot be the subject of a citizen petition submitted to the agency under a proposed rule published in the Nov. 30 Federal Register.

Citizen Petition Preemption Of FDA Action Barred Under Proposed Rule

Pending FDA actions cannot be the subject of a citizen petition submitted to the agency under a proposed rule published in the Nov. 30 Federal Register.

Citizen Petition Preemption Of FDA Action Barred Under Proposed Rule

Pending FDA actions cannot be the subject of a citizen petition submitted to the agency under a proposed rule published in the Nov. 30 Federal Register.

Topics

UsernamePublicRestriction

Register

PS088717

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel