What is GDUFA and PDUFA in pharma?

What is GDUFA and PDUFA in pharma

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.

GDUFA: Generic Drug User Fee Amendments. This law reduces costs to the industry while enabling the public to access safe and effective generic drugs.

PDUFA: “Prescription Drug User Fee Act” A United States law passed by Congress in 1992, the Prescription Drug User Fee Act, authorized the Food and Drug Administration (FDA) to collect fees from drug manufacturers to fund new drug approvals.

Hope you understand the difference between GDUFA And PDUFA in pharma

Reference: Prescription Drug User Fee Act Authorization

Also Read:

Impact of Contamination, Cross-contamination and Mix-ups

Difference Between 21 CFR Part 11 and EU Annex 11

Best Data Integrity Practices to avoid Data Integrity Issues

For Interview Preparation Refer: Interview

For interview preparation refer

YT channel: Pharmabeej

Leave a Comment

17 + 9 =

x