PDUFA
Acronymprescription-drug-user-fee-act, pdufa date, action dateDefinition
The Prescription Drug User Fee Act — the 1992 US law, renewed every five years, under which drug companies pay the FDA a fee with each application and the FDA commits to review timelines in return; in everyday use, the PDUFA date is the day by which the agency has said it will decide on a drug
The date the whole launch calendar hangs from. A brand site, its HCP and patient halves, the ISI, the disclosures and the approved claims are all built ahead of it and must be ready to go live the day the letter arrives — and ready not to, since the answer can be a complete response letter instead of an approval. Ten months for a standard review, six for priority, counted from the filing being accepted. For a web team the PDUFA date is the deadline that cannot slip, which is why launch-readiness work is sequenced backward from it.
Not a launch date — a decision date. Everything is built for it and nothing may say so publicly until the decision is the right one, which is the reason pre-approval sites are unbranded and the branded one waits behind a switch.