FDA Reopens Comment Period on the PDUFA Reauthorization

October 15, 2015

The Prescription Drug User Fee Act (PDUFA) gives FDA the authority to collect fees from companies that produce certain human drug and biological products.


PDUFA was enacted in order to help the Agency speed review times for New Drug Applications (NDAs) and Biologics License Applications (BLAs), by setting certain timelines and other benchmarks for review.

According to the Act, the fees are to be designated strictly for use for activities related to drug approvals by FDA’s Center for Drug Evaluation and Research (CDER) – NDAs – and FDA’s Center for Biologics Evaluation and Research (CBER) – BLAs.

PDUFA was authorized for the first time in 1992 and is required to be reauthorized every five years. The Act has been reauthorized four times since the initial approval, with the latest occurring in 2012 and the subsequent scheduled to take place in 2017.

Today, the US is known for reviewing and approving applications for new drugs in substantially less time than many other countries around the world, which leads to the belief that PDUFA has been a successful program thus far.

Let the Reauthorization Process Begin…

To kick off the reauthorization process, the first step is for FDA to announce a public meeting on the topic, where it asks the public for comments. FDA announced the initial notice in the Federal Register on May 13, 2015. In the notice, the Agency stated that it would hold a public meeting on July 15, 2015 , and comments from the public were to be submitted to the Agency (either electronically or in writing) no later than August 15, 2015.

FDA held the meeting on July 15, 2015, as scheduled (find the transcript, webcasts, and other info from the meeting here). The Agency received an abundance of comments covering a very wide range of topics, some of which were discussed. However, although although the initial timeframe ended two months ago, FDA recently announced that it will be reopening the comment period until April 29, 2016 in an attempt to “allow interested persons additional time to submit comments.”

For more information or to submit your comment(s) to FDA, view the announcement here.

Are you in the process of developing a drug or biological product? We can help you achieve successful interactions with the Agency and get your product approved by the FDA. Contact us today to learn more about our services and how we can be of assistance to you.



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