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

Drug Shortage Scrutiny: GAO Plans Study Of FDA’s Expedited Applications

Executive Summary

Government watchdog wants to look at how the agency expedites applications that could help alleviate a shortage, but cautions that process alone cannot reduce shortages.

You may also be interested in...



Drug Shortage Analysis Puts FDA At Loggerheads With GAO

GAO says ongoing drug shortages are increasing, but FDA says they are flattening; contrasting definitions of “shortage” produce the disparate results.

GOP Drug Shortage Strategy Pushes FDA Reform, Reimbursement Over Notification

House hearing includes arguments that regulatory delays thwart the market’s response to shortage price signals, suggesting reforms could be included in user fee legislation along with the popular early warning requirement.

An Orange Book By Any Other Name …

One of US FDA’s most important publications ever, the Orange Book celebrates 40 years as the definitive guide to approved drug products and therapeutic equivalents. Even as the color has receded from the book itself, orange still generates appreciation from regulators and outside attorneys.

Topics

UsernamePublicRestriction

Register

ID1132046

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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