Current regulatory approaches for accessing potential COVID-19 therapies
This commentary aims to elaborate challenges in the regulatory approaches for accessing and investigating COVID-19 potential therapies either with off-label use, compassionate use, emergency use or for clinical trials. Since no therapies have been formally approved and completely effective and safe...
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| Main Authors: | , , , , , , |
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| Format: | Book |
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Taylor & Francis Group,
2020-12-01T00:00:00Z.
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| 042 | |a dc | ||
| 100 | 1 | 0 | |a Vesa Halimi |e author |
| 700 | 1 | 0 | |a Armond Daci |e author |
| 700 | 1 | 0 | |a Simona Stojanovska |e author |
| 700 | 1 | 0 | |a Irina Panovska-Stavridis |e author |
| 700 | 1 | 0 | |a Milena Stevanovic |e author |
| 700 | 1 | 0 | |a Venko Filipce |e author |
| 700 | 1 | 0 | |a Aleksandra Grozdanova |e author |
| 245 | 0 | 0 | |a Current regulatory approaches for accessing potential COVID-19 therapies |
| 260 | |b Taylor & Francis Group, |c 2020-12-01T00:00:00Z. | ||
| 500 | |a 2052-3211 | ||
| 500 | |a 10.1186/s40545-020-00222-6 | ||
| 520 | |a This commentary aims to elaborate challenges in the regulatory approaches for accessing and investigating COVID-19 potential therapies either with off-label use, compassionate use, emergency use or for clinical trials. Since no therapies have been formally approved and completely effective and safe to date, the best clinical choice is acquired only after consistent and fair communication and collaboration between licensed clinicians, researchers, regulatory authorities, manufacturers and patients. | ||
| 546 | |a EN | ||
| 690 | |a covid-19 | ||
| 690 | |a regulatory | ||
| 690 | |a ema | ||
| 690 | |a fda | ||
| 690 | |a clinical studies | ||
| 690 | |a compassionate use | ||
| 690 | |a clinical practice | ||
| 690 | |a off-label use | ||
| 690 | |a emergency use | ||
| 690 | |a Therapeutics. Pharmacology | ||
| 690 | |a RM1-950 | ||
| 690 | |a Pharmacy and materia medica | ||
| 690 | |a RS1-441 | ||
| 655 | 7 | |a article |2 local | |
| 786 | 0 | |n Journal of Pharmaceutical Policy and Practice, Vol 13, Iss 1 (2020) | |
| 787 | 0 | |n http://dx.doi.org/10.1186/s40545-020-00222-6 | |
| 787 | 0 | |n https://doaj.org/toc/2052-3211 | |
| 856 | 4 | 1 | |u https://doaj.org/article/fc1fbfad4b8f4e3fb0b3944f76ab9822 |z Connect to this object online. |