Regulatory alignment in FDA expedited pathways for infectious diseases: a decadal review with predictive modeling insights
Nguyen Thanh Tam, Ahmed M Sayed, Mohammad Najm Dadam, Randa Elsheikh, Jeza Muhammad Abdul Aziz, Abdelrahman Gamil Gad, Thi Thu Hoai Nguyen, Phillip Tran, Zhilin Zhang, Norio Ohmagari, Nguyen Tien Huy · 2025
Read Regulatory alignment in FDA expedited pathways for infectious diseases: a decadal review with predictive modeling insights by Nguyen Thanh Tam, Ahmed M Sayed, Mohammad Najm Dadam, Randa Elsheikh, Jeza Muhammad Abdul Aziz, Abdelrahman Gamil Gad, Thi Thu Hoai Nguyen, Phillip Tran, Zhilin Zhang, Norio Ohmagari, Nguyen Tien Huy (2025) in the Tower of Babel, a free online library of public-domain works preserved in clean, searchable text. No sign-up. The full text is served as a plain-text file at a predictable URL, where text is present: https://antarctic-labs.com/tower-of-babel/pmc-12780218.txt.
Description
Nguyen Thanh Tam and colleagues published a 2025 review of fast-track drug approvals. The study covered a decade of United States approvals. Infectious disease drugs were the focus. Critics say they get less urgency than cancer drugs. The team compared development and review times across fields.
They examined nearly five hundred approved products. Records came from official drug and trial databases. Infectious products were compared with all others. Statistical tests measured delays and program use. The authors also built predictive models. Findings can guide fairer use of expedited pathways. Speed matters most when outbreaks will not wait.
Catalog record
| CREATOR | Nguyen Thanh Tam, Ahmed M Sayed, Mohammad Najm Dadam, Randa Elsheikh, Jeza Muhammad Abdul Aziz, Abdelrahman Gamil Gad, Thi Thu Hoai Nguyen, Phillip Tran, Zhilin Zhang, Norio Ohmagari, Nguyen Tien Huy |
|---|---|
| YEAR | 2025 |
| COLLECTION | PAPERS |
| FORMAT | TXT |
| FILE SIZE | 36 KB |
| VERSION | 1.0 |
| LICENSE | CC BY 4.0 |
| RIGHTS | CC BY |
| SOURCE | Europe PMC |