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

Will FDASIA Slow Things Down?

Executive Summary

During Elsevier Business Intelligence’s FDA/CMS Summit in December, FDA Office of New Drugs Director John Jenkins discussed the possible impact of the FDA Safety and Innovation Act, as compared to the significant burden posed by implementation of the 2007 FDA Amendments Act.

You may also be interested in...



First-Cycle Approval Rate Already High; Can PDUFA V Actually Boost It?

FDA official says the rate of approving applications in the first review cycle may not increase much more, even as the new review model, intended to promote more first-cycle approvals, has yet to finish with its inaugural applications.

PDUFA Performance In The FDAAA Era: Over One Third Of Novel 2009 CDER Approvals Took Advantage Of Relaxed User Fee Goal Interregnum

CDER met the user fee goals of almost two-thirds of new molecular entities and novel therapeutic biologics approved in 2009, even at the height of the almost two-year period when Office of New Drugs Director John Jenkins allowed reviewers to miss Prescription Drug User Fee Act action dates due to workload and resource constraints

Keeping Track: Cancer Approvals From Lumisight Imaging To Adjuvant Alecensa

The US FDA’s approval of Lumicell’s optical imaging agent Lumisight makes a dozen novel approvals in 2024 for the Center for Drug Evaluation and Research.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS055022

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