Scrip is part of the Business Intelligence Division 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

Surprisingly, Fewer 'Expedited' New Drug Approvals In 2015

This article was originally published in Scrip

Executive Summary

Even though the FDA's Richard Pazdur and his Office of Hematology and Oncology Products appeared to be on fire in 2015 – approving many medicines well ahead of their Prescription Drug User Fee Act (PDUFA) action date – there were fewer applications for novel drugs and biologics overall cleared for marketing under the agency's expedited pathways than a year earlier.






Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

All set! This Question has been sent to 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

Add a personalized Question to your Analyst