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


FDA advisory opinions and guidelines

Executive Summary

Cannot "be construed to bind FDA legally to a particular course of action" and FDA subsequently "can initiate regulatory action when consistent with applicable statutes and regulations," agency says in a proposed rule published in the Oct. 15 Federal Register. The clarification responds to a small number of court cases alleging that the advisory opinion and informal guidelines procedures appear to bind the agency to certain actions in conflict with the "general principle that the government may not be estopped" from enforcing other applicable statutes. FDA also is concerned about whether a purported obligation to follow the opinions and guidelines "may place inappropriate restrictions on FDA's ability to respond to specific situations in ways that best carry out its statutory responsibilities." Nonetheless, advisory opinions and guidelines continue to be "a reliable indication of the agency's expectations" and any "uncertainty resulting from the proposed revision should be minimal," FDA says. The revision does not affect final orders such as those issued through formal rule- making.

You may also be interested in...

Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance

FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials

Shire Hopes To Sow Future Deals With $50M Venture Fund

Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth




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