Declaration Fees

Notes: Before the market open for announcements released before ET of the FDA announcement dates; during market hours for those announced from to ET; after the market close for FDA notifications occurred after ET of the announcement dates or a couple of days after the FDA announcement dates.

A priority review designation is given to drugs that offer major advances in treatment, or provide a treatment where no adequate therapy exists. The 2002 amendments to PDUFA set a goal that a standard review of a new drug application be accomplished within a ten-month time frame.

The PDUFA date refers to the date the Food and Drug Administration (FDA) are expected to deliver their decision whether or not a approve a companies New Drug Application (NDA) or Biologics License Application (BLA). On the PDUFA date the FDA will either: - issue approval for marketing.

The action date tells when an FDA regulatory action, such as an original or supplemental approval, took place. FDA Application Number. This number, also known as the NDA (New Drug Application) number, is assigned by FDA staff to each application for approval to market a new drug in the United States.

User fee funding is critical to keeping the FDA staffed appropriately, helping the agency improve review and approval processes to support the economic benefits that new drug and device development contribute to the U.S. job creation and economic development.

User fees can entail any combination of drug costs, supply and medical material costs, entrance fees or consultation fees. They are typically paid for each visit to a health service provider, although in some cases follow-up visits for the same episode of illness can be covered by the initial payment.

All establishments required to register must first visit the Device Facility User Fee website to pay the user fee. Once you make payment and receive confirmation numbers for your payment (PIN/PCN), you can proceed to the FURLS website to complete your registration and listing requirements.

Industry users who have received FDA invoices in the mail may click on the specific user fee program link directly below to pay the invoices online. Users require a user name and password or valid access credentials to proceed once they get to the invoice payment pages.

A user fee is a sum of money paid as a necessary condition to gain access to a particular service or facility. Examples of user fees could include highway tolls or parking garages. People pay user fees for the use of many government-affiliated services and facilities as well.