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.
For reports 2014 and older visit Archived Annual Reports to Congress.
- Thirteenth Annual Report on Delays in Approvals of Applications Related to Citizen Petitions and Petitions for Stay of Agency Action for Fiscal Year 2020 (PDF - 176.19KB)
- Twelfth Annual Report on Delays in Approvals of Applications Related to Citizen Petitions and Petitions for Stay of Agency Action for Fiscal Year 2019 (PDF - 180.15 KB)
- Eleventh Annual Report on Delays in Approvals of Applications Related to Citizen Petitions and Petitions for Stay of Agency Action for Fiscal Year 2018 (PDF - 2.4 MB)
Tenth Annual Report on Delays in Approvals of Applications Related to Citizen Petitions and Petitions for Stay of Agency Action for Fiscal Year 2017 (PDF - 1.4 MB) - Ninth Annual Report on Delays in Approvals of Applications Related to Citizen Petitions and Petitions for Stay of Agency Action for Fiscal Year 2016
- Eighth Annual Report on Delays in Approvals of Applications Related to Citzen Petitions and Petitions for Stay of Agency Action for Fiscal Year 2015
- For reports 2014 and older visit Archived Annual Reports to Congress.
- Report to Congress: Second Annual Report on Drug Shortages for Calendar Year 2014
- Report to Congress: Implementation of Section 3507 of the Patient Protection and Affordable Care Act of 2010, Final Report
- Report to Congress: Implementation of Section 3507 of the Patient Protection and Affordable Care Act of 2010, First Progress Report, March 2011
- Report to Congress: Implementation of Section 3507 of the Patient Protection and Affordable Care Act of 2010, Second Progress Report, May 2012
- Report to Congress: Implementation of Section 3507 of the Patient Protection and Affordable Care Act of 2010, Third Progress Report, June 2013
- Seventh Annual Report on Delays in Approvals of Applications Related to Citizen Petitions and Petitions for Stay of Agency Action for Fiscal Year 2014
- Sixth Annual Report on Delays in Approvals of Applications related to Citizen Petitions and Petitions for Stay of Agency Action for Fiscal Year 2013
- Fifth Annual Report on Delays in Fifth Annual Report on Delays in Approvals of Applications Related to Citizen Petitions and Petitions for Stay of Agency Action for Fiscal Year 2012
- Fourth Annual Report on Delays in Approvals of Applications Related to Citizen Petitions and Petitions for Stay of Agency Action for Fiscal Year 2011
- Third Annual Report on Delays in Approvals of Applications Related to Citizen Petitions and Petitions for Stay of Agency Action for Fiscal Year 2010
- Second Annual Report on Delays in Approvals of Applications Related to Citizen Petitions and Petitions for Stay of Agency Action for Fiscal Year 2009 (PDF - 45KB)
- First Annual Report on Delays in Approvals of Applications Related to Citizen Petitions and Petitions for Stay of Agency Action for Fiscal Year 2008