BIO Analysis: Resubmissions After Third Round of FDA Review Not Worth the Effort

| 28 March 2012 |  By 

An analysis by the Biotechnology Industry Organization (BIO) of 748 new drug applications (NDAs) and biologics license applications (BLAs) shows a nearly 20% increase in the rate of approvals for second-round submissions in response to a first-round complete response letter (CRL).

The analysis, which tracked NDA and BLA submissions made between 2005 and 2010, shows a 55% approval rate for first-round submissions.

The total approval rate jumped nearly 20% to 74.6% after companies submitted responses to the US Food and Drug Administration's (FDA) CRLs. A third round of responses brought that percentage up an additional 8.3% to 82.9%.

From there, additional rounds of responses and submissions did not lead to significant increases in approvals. Fourth-round submissions increased the total by 1.2% (84.1%), and a fifth round of submissions only improved the total by 0.2% (84.3%).

"After [the third-round submission]", writes BIO, "there is little data to support that subsequent submissions materially impact the probability of approval."

The analysis sheds some light on the importance of regulatory quality in filings, and provides insight on FDA's drug approval ceiling and filing strategies.

"When we analyzed 83 NDA/BLA filings that never made it to approval (i.e. were finally suspended by the sponsor), only one was attributed to a manufacturing issue," writes BIO.

Read more:

BIO - Dealing with Rejection, the Regulatory Kind


© 2023 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy