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Draft FDA Guidance on User Fees

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A draft guidance has been issued for comment purposes only, see “Draft Guidance for Industry and FDA Staff: User Fees and Refunds for Premarket Approval Applications” issued March 13, 2009, which if issued as final, will replace the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