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

FDA New Drug Review Performance May Miss Lowered Expectations – Jenkins

Executive Summary

FDA's ability to meet its Prescription Drug User Fee Act deadlines for new product approvals may end up below the agency's earlier estimates, according to Office of New Drugs Director John Jenkins

You may also be interested in...



Sponsors Can Expect REMS Discussions As Early As Phase II, FDA Says

Though REMS requirements caused longer reviews in 2008, FDA Deputy Director Office of New Drugs Sandra Kweder said the agency expects "we will be doing this better and it will not affect PDUFA deadlines" going forward.

FDA’s Rollover Reviews: Missed Deadlines Could Inflate 2009 Approval Tally

FDA is heading into 2009 with at least a dozen missed review deadlines held over from 2008 - potentially setting up the agency and industry for what could be an unusually higher number of drug and biologic approvals this year

FDA’s Rollover Reviews: Missed Deadlines Could Inflate 2009 Approval Tally

FDA is heading into 2009 with at least a dozen missed review deadlines held over from 2008 - potentially setting up the agency and industry for what could be an unusually higher number of drug and biologic approvals this year

Related Content

Latest News
See All
UsernamePublicRestriction

Register

PS050142

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