Here is a link that will help you FDA: User Fees Explained and FDA posts FY2023 user fee tables In the US, the FDA has several user fee programs PDUFA, MDUFA, GDUFA, etc. established by law and reauthorized each 5 years by Congress for certain applications submitted for approval of a new drug (NDA) submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), or licensure of certain biological products (BLA) under section 351(a) of the Public Health Service Act (PHS Act), for example.
------------------------------
Juliane Carvalho RAC, MSc
Lead Regulatory Health Project Manager
United States
**My comments are an informal communication and represent my own best judgement. These comments do not bind or obligate the U.S. Food and Drug Administration**
------------------------------
Original Message:
Sent: 19-May-2023 12:49
From: Anonymous Member
Subject: Current IND/CTA Application Fees
This message was posted by a user wishing to remain anonymous
Hi esteemed colleagues,
Could someone please let me know what the current IND/CTA application fees are in the USA and EU (if applicable)?
If there's an online resource to find these information, I would appreciate that as well.
Thank you!