FDA Provides COVID-19 Guidelines for Patients With Cancer and Healthcare Providers
As the United States combats the COVID-19 coronavirus pandemic, federal agencies like the U.S. Food and Drug Administration’s (FDA’s) Oncology Center of Excellence (OCE) are reassuring specific populations, such as those in the cancer community, that the agency is still patient-centered in its mission.
“In this critical time, we want you to know that we are here for patients with cancer and their healthcare providers and we will do everything we can to help you through this difficult period,” OCE said in a March 23, 2020, message. “Although our nation’s emphasis is on the need to combat this virus, patients with cancer and their unique needs continue to be a top priority.”
OCE said that it would specifically prioritize:
Expediting oncology product development
Reviewing required modifications for clinical trials
Processing expanded access requests for investigational products.
Anticipating and preventing drug shortages
Informing the cancer community
OCE contributed to the FDA Guidance on Conduct of Clinical Trials of Medical Products (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-guidance-conduct-clinical-trials-medical-products-during-covid-19-pandemic) during the COVID-19 pandemic. Its call center, Project Facilitate (https://www.fda.gov/about-fda/oncology-center-excellence/project-facilitate), is open from 8 am–4:30 pm EST Monday–Friday at 240-402-0004 or ONCProjectFacilitate@fda.hhs.gov (mailto:ONCProjectFacilitate@fda.hhs.gov). For after-hours emergency requests, contact FDA’s Emergency Call Center at 800-300-4374.
Healthcare providers caring for patients with cancer and COVID-19 who are seeking an investigational treatment specifically to treat COVID-19 should contact the Division of Antivirals (https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/office-infectious-diseases-oid) directly to request access. Patients and caregivers who need information about accessing investigational therapies may contact the Division of Drug Information at 301-796-3400 or email email@example.com (mailto:firstname.lastname@example.org).
Report any shortage notifications and updates to FDA via email at email@example.com (mailto:firstname.lastname@example.org).