FY 2022 PDUFA Dear Colleague Letter

If your email program has trouble displaying this email, view as a webpage. FY 2022 PDUFA Dear Colleague Letter In preparation for FDA's FY 2022 PDUFA program fee invoices, the Dear Colleague Letter (DCL) was emailed on Monday, May 3, 2021.  Please submit your response to CDERCollections@fda.hhs.gov by Tuesday, June 1, 2021.  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" then "PDUFA Letters."    **Please note: This update is only applicable to companies that have PDUFA user fee eligible products for prescription drug program fees.** Learn More

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