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  1. Guidance, Compliance, & Regulatory Information

Frequently requested or proactively posted drug-specific and other records

Frequently requested or proactively posted drug-specific and other records

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Date Posted Records Description
5/3/2019 Decision to waive the requirement for a single, shared system REMS program for ambrisentan tablet products (dated March 22, 2019) (PDF - 61KB)
2/25/2019 TIRF FDA Memo on REMS Modification (10-31-2013) (PDF - 166KB)
2/25/2019 TIRF FDA Memo on REMS Modification (6-1-2012) (PDF - 91KB)
2/25/2019 ERLA Six-Month Assessment Report (PDF - 2.91MB)
9/26/2018 Adverse Event Reports for Pharmacovigilance Review of INSTIs and NTDs plus Spinal Malformations 6-13-18 (PDF - 1.16MB)
9/26/2018 Pharmacovigilance Review of INSTIs and NTDs plus Spinal Malformations 6-13-18 (PDF - 1.57MB)
3/28/2018 FDA Letter to USP: Drug Product Monographs for Biological Products (PDF - 609KB)
3/6/2018 Kratom additional death adverse event reports (PDF - 1MB)
2/9/2018 Decision to waive the requirement for a single, shared system REMS program for alosetron hydrochloride products (dated April 30, 2015) (PDF - 277KB)
2/6/2018 Adverse event reports regarding Kratom that resulted in death (PDF - 7MB)
8/31/2017 Additional Information NDA 206488 Exondys 51 (eteplirsen) Approval
3/27/2017 Teething Tablet Adverse Event Reports Part 1 of 3 (PDF - 57MB)
3/27/2017 Teething Tablet Adverse Event Reports Part 2 of 3 (PDF - 89MB)
3/27/2017 Teething Tablet Adverse Event Reports Part 3 of 3 (PDF - 22MB)
2/8/2017 Exclusivity Determination Memorandum for Morphabond (morphine sulfate) extended-release tablets for NDA 206544, (dated 11/16/16) (PDF - 420KB)
1/25/2017 Decision to waive the requirement for a single, shared system REMS for sodium oxybate oral solution (dated January 17, 2017) (PDF - 1.77MB)
9/27/2016 Recommendation to maintain marijuana in Schedule I of the Controlled Substances Act [Date Range May - June 2015] (PDF - 57MB)