Oncology Expanded Access and FDA's Project Facilitate.
Expanded Access
Food and Drug Administration
Oncology
Project Facilitate
Journal
The oncologist
ISSN: 1549-490X
Titre abrégé: Oncologist
Pays: England
ID NLM: 9607837
Informations de publication
Date de publication:
10 2021
10 2021
Historique:
received:
07
04
2021
accepted:
14
06
2021
pubmed:
22
7
2021
medline:
26
10
2021
entrez:
21
7
2021
Statut:
ppublish
Résumé
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.
Identifiants
pubmed: 34288259
doi: 10.1002/onco.13910
pmc: PMC8488788
doi:
Substances chimiques
Drugs, Investigational
0
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
e1880-e1882Informations de copyright
Published 2021. This article is a U.S. Government work and is in the public domain in the USA.
Références
Expanded Access. U.S. Food and Drug Administration Web site. Available at https://www.fda.gov/news-events/public-health-focus/expanded-access. Accessed March 9, 2021.
FDA Oncology Center of Excellence and Reagan-Udall Foundation: Project Facilitate & EA Navigator: Working Together to Enable Patient Access to Investigational Oncology Drugs. Public workshop. May 16, 2019. Available at https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/project-facilitate-ea-navigator-fda-oce-and-reagan-udall-foundation-working-together-enable-patient. Accessed March 9, 2021.
Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research, U.S. Food and Drug Administration. Individual Patient Expanded Access Applications: Form FDA 3926. Guidance for Industry. Silver Spring, MD: U.S. Food and Drug Administration, 2017. Available at https://www.fda.gov/media/91160/download. Accessed March 9, 2021.
Project Facilitate. U.S. Food and Drug Administration Web site. Available at https://www.fda.gov/about-fda/oncology-center-excellence/project-facilitate. Accessed March 9, 2021.
Expanded Access Navigator. Reagan-Udall Foundation Web site. Available at https://navigator.reaganudall.org/expanded-access-navigator. Accessed March 9, 2021.
Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research, U.S. Food and Drug Administration. Expanded Access to Investigational Drugs for Treatment Use-Questions and Answers. Guidance for Industry. Silver Spring, MD: U.S. Food and Drug Administration, 2017. Available at https://www.fda.gov/media/85675/download. Accessed March 9, 2021.
Documentation of informed consent. 21 CFR §50.27. April 1, 2020. Available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=50&showFR=1&subpartNode=21:1.0.1.1.20.2. Accessed on May 12, 2021.
Expanded Access Information for Industry: What are the reporting requirements for industry sponsors of expanded access? U. S. Food and Drug Administration Web site. Available at https://www.fda.gov/news-events/expanded-access/expanded-access-information-industry#Sponsors. Accessed March 9, 2021.
What is a serious adverse event? U. S. Food and Drug Administration Web site. Available at https://www.fda.gov/safety/reporting-serious-problems-fda/what-serious-adverse-event. Accessed May 12, 2021.