Question

What has been the main impact of the Prescription Drug User Fee Act on the drug approval process?

-"As a result of PDUFA, more new drugs have been approved by the FDA for marketing"
-"As a result of PDUFA, more drugs that have serious adverse health effects have been rejected by the FDA"
-"As a result of PDUFA, the average length of time from NDA filing to FDA decision has been significantly shortened"
-"As a result of PDUFA, there have been more drugs submitted to the FDA for marketing evaluation"
-"As a result of PDUFA, more drugs that are not effective have been withdrawn from the market"

Answer 1

The main impact of the Prescription Drug User Fee Act (PDUFA) on the drug approval process is a shortened average time from New Drug Application (NDA) filing to FDA decision, facilitating faster access to new treatments for patients.

Step-by-step explanation:

The Prescription Drug User Fee Act (PDUFA) has had a significant impact on the drug approval process.

One of the main effects of the PDUFA is that the average length of time from a New Drug Application (NDA) filing to an FDA decision has been significantly shortened.

This means that new therapies can reach the market more quickly, which is beneficial for patients awaiting new treatments.

The PDUFA enables the FDA to collect fees from drug manufacturers, which in turn are used to fund additional reviewers and resources to expedite the review process without compromising the safety and efficacy standards required for drug approval.