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Current regulatory approaches for accessing potential COVID-19 therapies.
Halimi, Vesa; Daci, Armond; Stojanovska, Simona; Panovska-Stavridis, Irina; Stevanovic, Milena; Filipce, Venko; Grozdanova, Aleksandra.
  • Halimi V; 1Faculty of Pharmacy, University Ss. Cyril and Methodius, Skopje, North Macedonia.
  • Daci A; 2Department of Pharmacy, Faculty of Medicine, University of Prishtina, Prishtina, Kosovo.
  • Stojanovska S; 3University Clinic of Hematology, Medical Faculty, University Ss. Cyril and Methodius, Skopje, North Macedonia.
  • Panovska-Stavridis I; 3University Clinic of Hematology, Medical Faculty, University Ss. Cyril and Methodius, Skopje, North Macedonia.
  • Stevanovic M; 4University Clinic of Infection diseases and febrile conditions, Medical Faculty, University Ss. Cyril and Methodius, Skopje, North Macedonia.
  • Filipce V; 5University Clinic for Neurosurgery, Medical Faculty, University Ss. Cyril and Methodius, Skopje, North Macedonia.
  • Grozdanova A; 1Faculty of Pharmacy, University Ss. Cyril and Methodius, Skopje, North Macedonia.
J Pharm Policy Pract ; 13: 16, 2020.
Article in English | MEDLINE | ID: covidwho-277152
ABSTRACT
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.
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Full text: Available Collection: International databases Database: MEDLINE Type of study: Prognostic study Language: English Journal: J Pharm Policy Pract Year: 2020 Document Type: Article

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Full text: Available Collection: International databases Database: MEDLINE Type of study: Prognostic study Language: English Journal: J Pharm Policy Pract Year: 2020 Document Type: Article