What is PDUFA VI?
The Prescription Drug User Fee Act (PDUFA VI) was first created in response to a bottleneck of new medicine approvals that left patients waiting for years for an under-staffed and under-funded U.S. Food and Drug Administration (FDA or Agency) to review new drug applications.
What happens after a PDUFA?
Faster Approvals Since PDUFA was passed in 1992, more than 1,000 drugs and biologics have come to the market.” The act establishes two time frames for gaining approval: Standard Review and Priority Review. The goal for standard review is to get a drug through the approval process in 10 months.
What percentage of PDUFA are approved?
In the first few years of the Prescription Drug User Fee Act (PDUFA) program, the first cycle approval rate for new drugs was as low as 23 percent. Now it is about 80 percent on average.
How long does it take to get PDUFA 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.
What happens on PDUFA date?
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.
What is a Pdufa priority review?
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.
Why is PDUFA important?
PDUFA continues to play a critical role in strengthening the FDA’s ability to review human drug applications. The program also provides biopharmaceutical companies with greater regulatory predictability, which fosters industry investment in research and development.
Can Pdufa come early?
So the company conducts all the clinical trials. Then it submits its application to the FDA with all the supporting data, and the FDA gives it the PDUFA date, at which point it will get that decision. And it could come early.