Is PDUFA date same as approval date?
Once the FDA accepts a filing for the approval of a drug, the agency must complete its review process within 10 months in most cases. The date at the end of the review period is referred to as the PDUFA date. In some instances, the FDA grants Priority Review status to the regulatory filing for a drug.
What does PDUFA stand for?
Prescription Drug User Fee Act
The Prescription Drug User Fee Act (PDUFA) was created by Congress in 1992 and authorizes FDA to collect fees from companies that produce certain human drug and biological products.
When does FDA announce PDUFA?
The PDUFA date is 10 months after the drug application has been accepted by the FDA or 6 months, if the drug is given a priority review designation.
What is PDUFA stock?
PDUFA Details and Market Impact
Specifically, a PDUFA date is the goal date set by the FDA for announcing its decision on a company’s New Drug Application/Biologics License Application/ Supplemental Biologics License Application (sBLA)/ Supplemental New Drug Application (sNDA) after reviewing applications.
Why is PDUFA date important?
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).
What percentage of PDUFA are approved?
The preliminary data show that the percentage of priority and standard applications filed in FY 2020 and approved during the first review cycle were 81 percent and 53 percent, respectively.
Why is PDUFA important?
PDUFA has played an essential role in strengthening FDA’s ability to support innovation while maintaining the Agency’s high standards for scientific rigor and patient safety.
Why is a PDUFA date important?
Does FDA approve before PDUFA date?
Can FDA miss PDUFA date?
A miss of the PDUFA date, essentially the “go/no-go date for drug approval” as Russo described it, would normally be bad news for a company. In some cases, it signals the FDA is not satisfied with the data they were provided.
How do PDUFA dates work?
PDUFA dates are deadlines for the FDA to review new drugs. The FDA is normally given 10 months to review new drugs. If a drug is selected for priority review, the FDA is allotted 6 months to review the drug. These time frames begin on the date that an NDA is accepted by the FDA as complete.