Drug story

Drug story: What is PDUFA date: It's the deadline by which the FDA must make a decision on a drug application.

In recent times, there is a race to promote drugs as soon as the FDA approves them. This ensures that manufacturers do not waste any precious time in commercialization after approval. Therefore, novel drugs or those with many competitors aim to expedite the marketing process, leading to a key milestone known as the PDUFA date. By the PDUFA date, drug companies strive to finalize contracts with third-party logistics (3PL) providers, specialty pharmacies, develop healthcare provider (HCP) target lists, create call plans, set up reporting dashboards, and identify sales representatives. This preparation minimizes downtime between FDA approval and the actual commercial promotion.

A PDUFA (Prescription Drug User Fee Act) date is a target date set by the U.S. Food and Drug Administration (FDA) to complete its review of a new drug application (NDA) or a biologics license application (BLA). For standard reviews, the PDUFA date is typically 10 months from the filing of the application, while for priority reviews, it is 6 months.

The FDA collects user fees from drug manufacturers regardless of whether the drug is ultimately approved or rejected. These fees support the FDA's review process and other regulatory activities. If you're submitting a new drug application with clinical data, the total initial cost would be $4 million plus the annual program fee of $0.4 million, making it $4.5 million.

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