FDA Provides COVID-19 Guidelines for Patients With Cancer and Healthcare Providers

April 03, 2020 by Alec Stone MA, MPA, Former ONS Director of Government Affairs and Advocacy

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: 

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 druginfo@fda.hhs.gov (mailto:druginfo@fda.hhs.gov).  

Report any shortage notifications and updates to FDA via email at drugshortages@fda.hhs.gov (mailto:drugshortages@fda.hhs.gov)

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