Oncology Expanded Access and FDA's Project Facilitate.
Oncologist
; 26(10): e1880-e1882, 2021 10.
Article
em En
| MEDLINE
| ID: mdl-34288259
ABSTRACT
The Oncology Center of Excellence at the U.S. Food and Drug Administration launched Project Facilitate on May 31, 2019, to assist oncology health care providers with Expanded Access requests for investigational drugs. Expanded Access, sometimes called "compassionate use," is a regulatory pathway for physicians caring for patients who have a life-threatening condition or a serious disease to gain access to an investigational drug for treatment when no comparable or satisfactory alternative treatment options are available. Herein we describe the Project Facilitate program and the process for requesting Expanded Access to an investigational drug.
Palavras-chave
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Drogas em Investigação
/
Ensaios de Uso Compassivo
Idioma:
En
Ano de publicação:
2021
Tipo de documento:
Article