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

Bio-Better Outcome On Biosimilars For FDA In Senate Funding Report

This article was originally published in The Pink Sheet Daily

Executive Summary

Pressure on agency to finalize biosimilar guidances is still there, but unlike in the House, the Senate doesn't set the deadlines.

You may also be interested in...



FDA Field Operations Would Endure Reductions Under Budget

President Obama’s FY 2016 blueprint includes cuts to ‘low-priority’ enforcement, surveillance and other activities in FDA human drugs and biologics programs, but still increases those operations overall.

‘Precision Medicine’ Gets R&D Funding Push In President’s Speech

President Obama highlights potential for personalized medicine in his State of the Union address and will seek a “major increase” in research and development funding.

Holding ANDA Labeling Review Until Late Cycle Could Minimize Delays From Last-Minute Changes

A GDUFA III adjustment could allow more labeling changes during the review cycle and reduce assessment cycles.

Topics

Related Companies

UsernamePublicRestriction

Register

PS078695

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