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The new drug application (NDA) review has changed by both the Prescription Drug User Fee Act (PDUFA) and the FDA Modernization Act (FDAMA) in our federal government system. PDUFA allows the FDA to collect fees from sponsor companies who submit applications for review. The fees are used to update facilities and hire and train reviewers. To give you an idea, it’s an average of a hundreds of thousands of dollars if not millions just to submit an NDA at the FDA. PDUFA usually is renewed and currently we are at PDUFA VI.

Here is the fee schedule based off PDUFA:

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Program Fiscal Year 2019 Fiscal Year 2018
Requiring clinical data $2,588,478 $2,421,495
Not requiring clinical data $1,294,239 $1,210,748
Program fee $309,915 $304,162

If you would like to learn more regulatory information and review the fees for the other acts such as the Generic Drug User Fee Amendments (GDUFA II) to help fund review of generic drugs, the Biosimilar User Fee Amendments (BSUFA II) to help fund review of biosimilar drugs, or the Medical Device User Fee Amendments (MDUFA IV) to help fund review of medical devices, you can visit the Regulatory Affairs Professional Society (RAPS) at the following link:

This is a why many pharmaceutical companies stress on having a strong regulatory affairs department to ensure acceptance of their drug into market, not just for profitability, but also avoiding the hassles of a delayed approval. In addition, PDUFA requires the FDA to speed up their approval time and is expected by industry due to increased fees to file an NDA. Luckily, the results of the PDUFA legislation were significant; approval rates have increased from approximately 50% to near 80% and the review times have decreased to less than 15 months for most applications.

You’ll notice that every couple of years, FDAMA reauthorizes PDUFA which is where the numbers come in after the name (i.e. currently we are on PDUFA VI). It waives the user fee to small companies who have fewer than 500 employees and are submitting their first application. It allows payment of the fee in stages and permits some percentage of refund if the application is refused. Also, it exempts applications for drugs used in rare conditions (orphan drugs), supplemental applications for pediatric indications, and applications for biological used as precursors for other biologics manufacture. In addition, FDAMA permits a “fast-track” approval of compounds that demonstrate significant benefit to critically ill patients, such as those who suffer from AIDS, hepatitis C, and other specialty disease states. The intricacies and complexities are much more than what is reviewed in this guide and may not be needed to study for your MPJE exam.


Biologics are defined ...

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