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COVID-19 Implications for I-O Patient Management

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EXPANDED ACCESS: oncology care AND ANTIVIRALS for COVID19

  • 1.  EXPANDED ACCESS: oncology care AND ANTIVIRALS for COVID19

    Posted 8 days ago
    FDA continues to process Expanded Access requests for investigational products.

    Project Facilitate remains open at (240) 402-0004 or ONCProjectFacilitate@fda.hhs.gov from 8 a.m. to 4:30 p.m. Eastern time, Monday through Friday, to assist oncology health care providers and regulatory professionals in requesting access to investigational therapies for patients for the treatment of cancer when no satisfactory therapies are available and there is no opportunity for the patient to enroll in a clinical trial. For after-hours emergency requests, contact FDA's Emergency Call Center at 1-800-300-4374.

    Health care 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 or CBER 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.


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    Fernanda Arnaldez MD
    Executive Director, Global Clinical Development
    MacroGenics, Inc.
    Rockville MD
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  • 2.  RE: EXPANDED ACCESS: oncology care AND ANTIVIRALS for COVID19

    Posted 7 days ago
    What will I do

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