What is current PDUFA?
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. Since the passage of PDUFA, user fees have played an important role in expediting the drug approval process.
Can FDA extend PDUFA date?
The company had submitted data from an updated overall survival (OS) analysis to the FDA on February 2022. The submission constituted a major amendment to the applications, prompting the FDA to extend the PDUFA date to allow for a full review of the submissions.
What happens on a PDUFA date?
Prescription Drug User Fee Act (PDUFA) dates refer to deadlines for the FDA to review new drugs. 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 happens after a PDUFA date?
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.
Does FDA approval increase stock price?
Result: You can see the stock experienced a slight increase after the FDA approval start date in early May. Subsequently the stock continued a steady increase of 17% between the start and end of the approval process.
What happens after PDUFA approval?
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.
Do Stocks Go Down After FDA approval?
Answering the question, “Does a Drug Approval Mean a Higher Stock Price?” is fairly straight forward, but there are some caveats that investors need to be aware of. The simple answer is yes, in most cases a new drug approval can lead to a higher share price for the company on the receiving end of that approval.
How much does FDA approval affect stock price?
Should you sell after FDA approval?
Based on these observations, we posit that acting immediately after FDA approval may be the best strategy – whether by selling the stock or shorting it.
Is PDUFA still in effect?
In August 2017, the FDA Reauthorization Act of 2017 (FDARA) was enacted, which renewed the prescription drug user fee program (PDUFA) for a sixth time. The current legislative authority for PDUFA VI expires in September 2022.
What does PDUFA stand for?
The Food and Drug Administration (FDA or Agency) is announcing a virtual public meeting to discuss the proposed enhancements for the reauthorization of the Prescription Drug User Fee Act (PDUFA) for fiscal years (FYs) 2023 through 2027. Meeting Information
What is the PDUFA reauthorization?
On August 18, 2017, the President signed into law the Food and Drug Administration Reauthorization Act (FDARA), which includes the reauthorization of PDUFA through September 2022. PDUFA VI will provide for the continued timely review of new drug and biologic license applications.
What if I do not receive my PDUFA invoice by August 25?
If you do not receive your invoice by August 25, 2021, please contact PDUFA User Fee staff at [email protected]. CDER’s Work to Meet User Fee Goals During the Pandemic: This webpage will provide periodic updates on key user fee metrics related to application review and the pre-approval process throughout the COVID-19 pandemic.