What is a result of the Prescription Drug User Fee Act PDUFA of 1992?
What is a result of the Prescription Drug User Fee Act PDUFA of 1992?
Passed House amended (09/22/1992) Prescription Drug User Fee Act of 1992 – Amends the Federal Food, Drug, and Cosmetic Act to provide authority for the Secretary of Health and Human Services to assess and collect fees from manufacturers of prescription drugs beginning in FY 1993.
What is PDUFA action 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.
What is PDUFA VII?
One of the biopharmaceutical industry’s most closely watched forthcoming regulatory developments is the FDA’s imminent reauthorization of the Prescription Drug User Fee Act (PDUFA). PDUFA VII, as the reauthorization is commonly known, will cover the fiscal years 2023-2027.
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.
How is PDUFA date determined?
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.
How is Pdufa date determined?
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.
What is PDUFA and Gdufa?
GDUFA and PDUFA are US FDA programs that are designed to help the agency hire and retain a sufficient number and types of technical and scientific experts to evaluate human drug applications (NDAs and ANDAs) efficiently and predictably. GDUFA is associated with ANDAs, whereas PDUFA is associated with NDAs.
Why was the PDUFA created?
Its goals were to speed up FDA’s review of new drug applications for approval and to diminish its backlog of applications. PDUFA specified the activities on which FDA could spend the fees; most of the collections were to be used to hire additional reviewers.