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  1. CDER FOIA Electronic Reading Room

Frequently requested or proactively posted drug-specific and other records

Date Posted Records Description
5/21/2024 Drug Approval Package: JAYPIRCA
11/9/2023 First Interchangeable Exclusivity Expiration Memorandum for Cyltezo October 3, 2023 (PDF - 1.41MB)
5/15/2023 Adverse event report for Syfovre (PDF - 126KB)
5/19/2022 Epidemiology Review: Consumer Opioid Disposal Literature Scan and Search Results (dated April 29, 2021) (PDF - 569KB)
7/31/2020 FDA Letter to USP:  Reporting Threshold in USP-NF Monographs
6/30/2020 COVID-19 Related Records
5/20/2020 Exclusivity Summary for Testosterone undecanoate (oral) (dated August 6, 2019) (PDF - 110KB)
5/20/2020 Exclusivity Summary for Testosterone undecanoate (oral) (dated March 27, 2019) (PDF - 50KB)
8/5/2019 Additional Information on Transmucosal Immediate Release Fentanyl (TIRF) REMS
2/25/2019 Additional Information on Extended-Release (ER) and Long-Acting (LA) Opioid Analgesics REMS
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

 

 
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