FY 2027 PDUFA Dear Colleague Letter

https://www.fda.gov/industry/prescription-drug-user-fee-amendments/letters-pdufa?utm_medium=email&utm_source=govdelivery In preparation for FDA’s FY 2027 PDUFA program fee invoices, the Dear Colleague Letter (DCL) was emailed on Monday, May 4, 2026. Please submit your response to CDERCollections@fda.hhs.gov by Monday, June 1, 2026.