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Annual CDER Reports to Congress

Annual CDER Reports to Congress

In FDA’s Tenth Annual Report on Delays in Approvals of Applications Related to Citizen Petitions and Petitions for Stay of Agency Action for Fiscal Year 2017, we inaccurately reported that during the reporting period of Oct. 1, 2016, through Sept. 30, 2017, the approval of one 505(b)(2) application was delayed for 28 days because of a 505(q) petition.  In fact, that application was delayed during fiscal year 2016, and we already reported that delay in the Ninth Annual Report on Delays in Approvals of Applications Related to Citizen Petitions and Petitions for Stay of Agency Action for Fiscal Year 2016.  Accordingly, the 2017 Report should have reflected that no applications were delayed.