Αποτελέσματα Αναζήτησης
FDA Approved or Authorized Drugs to Reduce the Risk of Hospitalization or Death for Patients with Mild to Moderate COVID-19. FDA Approved or Authorized Drugs or Renal Replacement...
- Coronavirus Treatment Acceleration Program (Ctap)
In response to the novel coronavirus (COVID-19), FDA quickly...
- Karen Baker
November 1, 2023 Pfizer, Inc. Attention: Karen Baker...
- Veklury (Remdesivir)
FDA approved the antiviral drug Veklury (remdesivir) for...
- Coronavirus Treatment Acceleration Program (Ctap)
5 Δεκ 2023 · This guidance describes FDA’s current recommendations for phase 2 and phase 3 trials with a focus on trial population, trial design, efficacy endpoints, safety considerations, and...
7 Νοε 2023 · FDA is issuing this guidance to provide recommendations to sponsors of master protocols evaluating drugs for the treatment or prevention of COVID-19.
12 Μαΐ 2020 · This Viewpoint reviews the FDA’s May 2020 Emergency Use Authorization of the antiviral drug remdesivir for treatment of COVID-19 and discusses the need for a transparent distribution plan of a drug not otherwise available in the US and for which demand will likely exceed supply.
24 Ιουν 2021 · FDA is issuing this guidance to assist sponsors developing master protocols for trials evaluating drugs and biological products for the treatment or prevention of COVID-19.
20 Νοε 2020 · The Food and Drug Administration (FDA) approves vaccines when their benefits outweigh the risks for their intended use. In this article we review the standard FDA approach to vaccine evaluation, which underpins its current approaches to assessment of vaccines to prevent coronavirus disease 2019 (COV …
19 Απρ 2023 · This Review article summarizes progress with COVID-19 drug discovery, and discusses the lessons learned about aspects such as drug repurposing, disease models and clinical development...
