Compassionate Drug Use - Time Arising for a New Law in Bulgaria in the Era of COVID-19.

Nigyar DzhaferJannis Vasileios Papathanasiou

Published in: Folia medica (2020)

The global pandemic mandates Bulgarian Drug Agency for a reasonable update of the existing national regulation concerning compassionate use and off-label therapies. In the era of COVID-19, it is important for Bulgarian patients to have early and expanded access to investigational drugs for compassionate use.

Keyphrases

coronavirus disease
sars cov
end stage renal disease
ejection fraction
newly diagnosed
chronic kidney disease
peritoneal dialysis
respiratory syndrome coronavirus
prognostic factors
emergency department
clinical trial
quality improvement
drug induced
patient reported outcomes
open label
study protocol