Additional Information on Transmucosal Immediate Release Fentanyl (TIRF) REMS
The documents linked on this page have been redacted for certain information that is exempt from disclosure under the Freedom of Information Act, 5 U.S.C. sec. 552. This includes, for example, trade secret information, confidential commercial information, predecisional/deliberative-process information, and personal privacy information. The full text of any published materials within this document collection, including newspaper and journal articles, will not be posted to this website because such material is copyright protected.
- Fentanyl citrate ANDAs correspondence reviews 2010 to 2017
- Fentora fentanyl citrate correspondence reviews 2012 to 2017
- Subsys fentanyl sublingual spray correspondence meeting minutes reviews 2007 to 2017
- TIRF DMF Annual Report 2014 08-20
- TIRF DMF Annual Report 2015 08-20
- TIRF DMF Annual Report 2016 08-18
- TIRF DMF RADARS Report for Surveillance Monitoring period July 1 2012 to September 30 2013 to 2014 03-31
- TIRF DMF Response to FDA Information Requests on Forty-Eight Month REMS Assessment 2017 01-30
- TIRF FDA Memo on draft REMS Materials 2017 06-27
- TIRF FDA Memo on Interim Comments on REMS Set 1 2013 02-01
- TIRF FDA Memo on Interim Comments on REMS Set 2 2013 07-24
- TIRF FDA Memo on REMS Modification Final Review 2014 12-16
- TIRF FDA Memo on REMS Modification Review Interim Comments 1 2014 11-04
- TIRF FDA Memo on REMS Modification 2012 06-01
- TIRF FDA Memo on REMS Modification 2013 10-31
- TIRF FDA Memo on REMS Modification 2017 07-12
- TIRF FDA Memo on REMS Modification 2017 08-30
- TIRF FDA Memo on REMS Modification Interim Comments 1 2014 10-20
- TIRF FDA Memo on Responses to FDA Inquiry Received on 16 April 2013 to
2017 05-13 - TIRF FDA Memo on Responses to TIRF Industry Group 2017 09-21
- TIRF FDA Memo on Responses to TIRF Industry Group 2017 11-15
- TIRF FDA Memo on TIRF REMS Modification 1 2012 06-01
- TIRF FDA Review of Sixty Month REMS Assessment 2017 12-04
- TIRF Forty-Eight Month REMS Assessment 2015 12-28
- TIRF Six Month REMS Assessment 2013 09-12
- TIRF Sixty Month REMS Assessment 2016 12-28 and Supplemental Report 2017 02
- TIRF Thirty-Six Month REMS Assessment 2014 12-26
- TIRF Twelve Month REMS Assessment 2013 09-18
- TIRF Twenty-Four Month REMS Assessment 2013 12-27