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 Prevention May Fall To Payers As FDA Rolls Out New Reg

This article was originally published in The Pink Sheet Daily

Executive Summary

Even as agency touts its progress and expands its powers, it acknowledges the limits of notification.

You may also be interested in...



FDA Shortage Notification Mandate May Not Extend To Biologics

The agency has the option to issue regulations requiring biologics manufacturers to notify FDA of emerging production problems, but so far it’s only “something that we’re thinking about.”

Drug Shortage Bill In House Refines Hatch Reimbursement Proposal

Sterile injectable products with three or fewer manufacturers would get better federal reimbursement rates in an effort to attract more producers to the market; H.R. 6611 was modeled after a similar proposal from Sen. Orrin Hatch, R-Utah.

FDA’s Drug Shortage Reg Adds More Manufacturers, Products To Notification List

Interim final rule redefines the terms “sole manufacturer” and “discontinuance.”

Topics

UsernamePublicRestriction

Register

PS074980

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