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

REMS That Block Generics Are ‘Major’ Problem For FDA, Jenkins Says

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Chief of new drugs office notes unintended consequence of safety legislation is thwarting development of ANDAs and biosimilars.

You may also be interested in...



REMS And Generics: GPhA Needs Legislation, Continues Education

GPhA says congressional action is only remedy after study estimates $5.4 billion in potential savings is lost annually because of brand manufacturers using REMS to prevent generic competition.

FDAAA Fading? REMS Use Continues To Decline As Drug Safety Law Matures

FDA’s use of REMS continues to fall to almost undetectable levels, with the agency using the safety tools just a handful of times in the sixth full year of the program. REMS are now very much the exception and not the rule for new products – but still a very important exception.

Did PDUFA V Pass Too Quickly?

The pending Supreme Court decision on the Affordable Care Act may have forced negotiators to finish quicker than they would have liked as legislators indicate some more time may have produced an agreement on track-and-trace standards; stakeholders may question whether the bill could have been improved had the deadline not been looming.

Topics

Related Companies

UsernamePublicRestriction

Register

LL016481

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