Approval pathway not speeding up process, study shows

8 March 2017

The 505(b)(2) approval pathway for New Drug Applications (NDAs) in the USA is not shortening approval times, according to an analysis conducted by research group the Tufts Center for the Study of Drug Development (CSDD).

This streamlined development process is aimed at avoiding unnecessary duplication of studies performed on a previously approved drug, but it should not prompt companies filing NDAs to bring forward launch dates, the study suggests.

Joseph DiMasi, director of economic analysis at Tufts CSDD and principal investigator for the study, said: “While the 505(b)(2) regulatory pathway has been highly successful in bringing new therapies to market from 2009 through 2015, drug products approved under this pathway had a longer average approval time compared to new molecular entities approved during the same period.”

This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Try before you buy

Free

7 day trial access

Take a Free Trial

All the news that moves the needle in pharma and biotech
Exclusive features, podcasts, interviews, data analyses and commentary from our global network of life sciences reporters.
Receive The Pharma Letter daily news bulletin, free forever.

Become a subscriber

£820

Or £77 per month

Subscribe Now

Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
Daily roundup of key events in pharma and biotech.
Monthly in-depth briefings on Boardroom appointments and M&A news.
Choose from a cost-effective annual package or a flexible monthly subscription

The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK