If your email program has trouble displaying this email, view as a webpage.

FY 2027 PDUFA Dear Colleague Letter

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.  If you have any questions regarding the DCL, please send an email to the Dear Colleague Letter Coordinator at CDERCollections@fda.hhs.gov. 

The DCL is available at: https://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm149212.htm.  The DCL is also available on the PDUFA website, under “Related Info” -> “PDUFA Letters.”