PDUFA Fee NDA

Where I can get frequently asked questions about the Prescription Drug User Fee Act (PDUFA) permits FDA? I want get this following information, so please provide me following information and give these frequently asked questions about Prescription Drug User Fee Act (PDUFA) in PDF file.

Hi buddy here I have come to get info related to Prescription Drug User Fee Act (PDUFA) in New Drug Application (NDA) reference so will you plz let me know about the same here ??

[pooja]

Prescription Drug User Fee Act (PDUFA) provides the U.S. Food and Drug Administration (FDA) with necessary resources to meet performance goals for the regulatory review of new medicines.


PDUFA is critical to ensuring Americas biopharmaceutical companies can continue scientific innovation and bring new treatments to help patients live longer, healthier lives.

PDUFA working

To help make the review process more efficient, biopharmaceutical companies pay three different user fees under PDUFA:

Application fees:
Fee due when a sponsor submits a New Drug Application (NDA) or Biologics License Application (BLA).

Product fees:
Annual fee for marketed drugs for which no generic versions are approved.

Establishment fees:
Annual fee for each manufacturing site that manufactures at least one approved prescription drug for which no generic versions are approved.

Hii sair, I Wants to get the Information About the Prescription Drug User Fee Act Will you Please provide It ?

[pawan]

The Prescription Drug User Fee Act (PDUFA) was a law passed by the United States Congress in 1992 which allowed the Food and Drug Administration (FDA) to collect fees from drug manufacturers to fund the new drug approval process.

Drug launches

Faster drug approval times and other PDUFA-related changes have led to pharmaceutical companies targeting more drugs for first launch in the United States thus increasing patient access to new medicines. Faster drug review from 1990 to 2001 were found to increase the probability of a drug being launched first in the United States by 14%

Scale of fees

FDA calculates fees based on an annual basis. For fiscal year 2018, drug application fees are:
$2,421,495 per full application requiring clinical data,
$1,210,748 per application not requiring clinical data or per supplement requiring clinical data.
$304,162 for programs

Codification

Acts amended
Federal Food, Drug and Cosmetic Act
Titles amended
21 U.S.C.: Food and Drugs
U.S.C. sections amended
21 U.S.C. ch. 9, subch. VII