Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

Generic Program Is Biggest Extra Item In Senate User Fee Reauthorization Bill

Executive Summary

US FDA would need additional appropriations to cover all activities contemplated in the legislation – and the bill appears to need a pay-for because it increases the deficit.

You may also be interested in...



FDARA Would Trim $72 Million From Deficit Over 10 Years, CBO Says

CBO score of the FDA use fee reauthorization bill only looks at changes in revenues and direct spending on a few provisions, and does not factor in changes in discretionary spending.

FDARA Would Trim $72 Million From Deficit Over 10 Years, CBO Says

CBO score of the FDA use fee reauthorization bill only looks at changes in revenues and direct spending on a few provisions, and does not factor in changes in discretionary spending.

Best Of Biosimilar Agreement: FDA, Industry Tout Written Response, Pre-Submission Meeting

FDA's Leah Christl and Amgen and Sandoz representatives discuss key achievements of BsUFA II at DIA meeting; Christl expects to see interchangeable biosimilars come to market within the next two years.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS120905

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