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

Biosimilar User Fee Talks Reach Starting Line As Report Shows Growing FDA Workload

This article was originally published in The Pink Sheet Daily

Executive Summary

Agency staff efforts dedicated to 351(k) reviews increased more than 10-fold in fiscal year 2015, Eastern Research Group says.

You may also be interested in...



FDA Sets New Goal For Biosimilar, Drug Promotion Guidances

Agency plans to issue 102 new and revised draft guidances this year, including those on use of multiple endpoints in clinical trials, 180-day exclusivity, and ANDA refuse-to-receive standards.

Biosimilar User Fee Negotiations Won't Start Until 2016

Mid-December kick-off meeting puts emerging user fee program on much later track than others.

Drug Shortages, Inspections In Focus At US FDA Appropriations Hearing

Commissioner Robert Califf discussed the agency’s request for $12.3m to address shortages and legislation to require that manufacturers provide more detailed information about increased demand and supply chain vulnerabilities.

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS079205

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