| 4/1/2026 |
Letter on Hemp-Derived Cannabidiol Products in Medical Research Models (PDF – 212 KB) |
| 2/24/2025 |
Product Resolution of Tirzepatide Injection Shortage and Supply Status (PDF – 1.103 KB) |
| 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 |
Source
Clinical :: Oncology :: Nuclear :: Geriatric :: Regulatory :: Technology :: Consulting
"My passion is helping businesses, small and large, perform at their best." - Felicia Udoji-Eddings, Pharm.D.
Dr. Felicia Udoji-Eddings is the Founder and CEO of The Health Pals Company, a vertically integrated Healthcare System. As an experienced Clinical Pharmacy Leader, Pharmacy Consultant, Healthcare Executive, and Licensed Pharmacy Practitioner with deep backgrounds in Information Technology (IT), Scientific Research, and Business Management. Dr. Udoji-Eddings has a strong track record of exceptional performance in different business environments. A skilled Business Strategist, Dr. Udoji-Eddings has tackled complex problems and helped several organizations refocus their strategy in tough economic times. As a highly motivated and proactive individual, Felicia enjoys working with teams, in various capacities, to facilitate positive outcomes.