Guidance for Industry and FDA: User Fees and Refunds for Premarket Approval Applications
A draft guidance has been issued for comment purposes only, see “Draft Guidance for Industry and FDA Staff: User Fees and Refunds for Premarket Approval Applications” issued March 13, 2009, which if issued as final, will replace the currently available guidance which was issued on November 24, 2003.
Draft FDA Guidance on User Fees