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

CDER New Drug Reviews Are At 80%-90% Of User Fee Goals, Jenkins Says

Executive Summary

The Center for Drug Evaluation and Research's performance in review applications for new drugs and biologics within the timelines specified by the Prescription Drug User Fee Act has slipped to 80 percent to 90 percent

You may also be interested in...



FDA New Drug Review Performance May Miss Lowered Expectations – Jenkins

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

FDA New Drug Review Performance May Miss Lowered Expectations – Jenkins

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

FDA Amendments Act Implementation Faces Delay; Agency To Miss Deadlines

FDA is expected to miss a spate of implementation deadlines for provisions of the FDA Amendments Act as the law approaches its first anniversary

Related Content

Latest Headlines
See All
UsernamePublicRestriction

Register

PS049985

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