science

PDUFA date

PDUFA date is a science topic covered in the lgStudy science library. This page brings together a partial reference excerpt, illustrations, worked examples, real-world applications and a short study plan, so you can understand PDUFA date rather than just read about it. In short: In United States pharmaceutical regulatory practice, the PDUFA date is the colloquial name for the date by which the Food and Drug Administration must respond to a New Drug Application or a Biologics License Application. It is part of the regime established by the Prescription Drug User Fee Act to ensure funding of the Food and Drug Administration's drug approval activities in return for adhering to a largely fixed…

Key takeaways

PDUFA date belongs to science; place it in that map before memorising details.
Learn the definition first, then one example that makes the definition concrete.
Connect PDUFA date to a quantity you can measure, compute or draw — that is where exam questions come from.
Reproduce the core statement of PDUFA date from memory before moving on to harder problems.

Reference excerpt

In United States pharmaceutical regulatory practice, the PDUFA date is the colloquial name for the date by which the Food and Drug Administration must respond to a New Drug Application or a Biologics License Application. It is part of the regime established by the Prescription Drug User Fee Act to ensure funding of the Food and Drug Administration's drug approval activities in return for adhering to a largely fixed timetable of regulatory actions.

History Prior to the Prescription Drug User Fee Act (PDUFA), median approval times of New Drug Applications ranged between 21 and 29 months. The Prescription Drug User Fee Act was first passed in 1992 to facilitate the funding of the Food and Drug Administration while ensuring a more predictable timetable for drug approvals. Under the PDUFA regime, New Drug Applications and Biologics License Applications (together referred to as 'human drug applications' in the PDUFA context) are levied a fee upon filing. As of 2021, this fee was US$2,875,842 for applications requiring clinical data and US$1,437,921 for applications that do not. In return, the FDA strives to complete review of applications within 10 months for most applications and 6 months for priority reviews. The PDUFA date thus serves as a 'best estimate' of when a decision on a New Drug Application or a Biologics License Application would be forthcoming. This response may be a decision to approve the application or a Complete Response Letter (CRL). The PDUFA date may be extended by the Food and Drug Administration in certain circumstances. These include circumstances such as a 'major amendment', e.g. where data submitted to a final study report is updated or data inadvertently omitted is supplied. The PDUFA must be reauthorized every five years. The current version, PDUFA VII, was reauthorized as part of the Food and Drug Administration Reauthorization Act (FDARA) signed on 30 September 2022. The reauthorization will expire in September 2027.

Relevance The PDUFA date serves as a good first approximation of when a final decision on drug approval can be expected. Sponsors frequently publish PDUFA dates for their pending applications, and while there is no official list of PDUFA dates, several websites collect PDUFA dates from press announcements in a calendar form.

References

Worked examples

Example 1 — a first encounter with PDUFA date

Start with the simplest possible case. Write down what PDUFA date claims or describes in one sentence, then invent the smallest concrete situation in which that sentence is true. In science, the smallest case is usually a single object, a single equation or a single measurement. Check that every symbol or term in your sentence has a meaning in that case.

Example 2 — changing one variable

Take the situation from Example 1 and change exactly one quantity: double it, halve it, or set it to zero. Predict what should happen to PDUFA date before you calculate. Comparing your prediction with the result is the fastest way to find out whether you understand the idea or only the words.

Example 3 — an exam-style question

Typical questions about PDUFA date ask you to (a) state it precisely, (b) apply it to given data, and (c) explain a limitation. Practise writing all three answers in under five minutes; the third part is what separates a full-mark answer from an average one.

Applications of PDUFA date

In research: PDUFA date appears in science research whenever the underlying quantities have to be modelled precisely. Papers usually cite it as a starting assumption and then explore where it breaks down.
In technology and industry: Engineering practice reuses PDUFA date in design rules, simulations and safety margins. Knowing the idea lets you read a specification sheet and understand why the numbers look the way they do.
In the classroom: PDUFA date is common in secondary-school and first-year university syllabi. It links to neighbouring topics Drug development, Food and Drug Administration, Pharmaceutical regulation in the United States, so understanding it makes those chapters shorter.
In everyday life: Look for PDUFA date outside the textbook — in sport, cooking, traffic, electronics or the sky above you. An example you found yourself is remembered far longer than one you were given.

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How to study PDUFA date in 20 minutes

Read the reference excerpt below once, without taking notes.
Close the page and write down what PDUFA date means in your own words.
Compare your version with the excerpt and mark what you missed.
Work through the three examples above with pen and paper.
Explain PDUFA date out loud to somebody else — or to Teacher Smith in the lgStudy chat.

Frequently asked questions

What is PDUFA date in simple terms?

Why does PDUFA date matter?

Because it connects several science ideas at once: it gives you a definition you can apply, a quantity you can calculate, and a way to check whether a result is plausible.

How should I study PDUFA date?

Read the excerpt, restate it from memory, then work through the examples and applications listed on this page. The five-step study plan above takes about twenty minutes.

What does this page cover?

It gives you a compact reference excerpt plus original lgStudy explanations, examples, applications and study material on PDUFA date.