As we continue to face a worldwide public health crisis, the Reagan-Udall Foundation is your connection to the latest, science-based information regarding COVID-19 and the products we use, the food we eat, and the medicine we take.
Updates from the FDA
Navigating Medical & Treatment Developments for COVID-19
The COVID-19 Treatment Hub provides physicians, patients, and caregivers with information about the latest research in the fight against COVID-19. Many companies are currently developing new therapies and vaccines for coronavirus and/or evaluating how drugs that are currently available may treat the symptoms of COVID-19.
While the FDA continues its important work to approve or authorize more medical products to treat, cure, or prevent COVID-19, there are already several available to physicians, patients, and caregivers. In addition to these available therapies and vaccines are other options for patients, such as enrolling in a clinical trial or requesting access to investigational products being tested by biopharmaceutical companies.
Clinical trials are necessary to gain regulatory approvals so new treatments are broadly available to patients as quickly as possible. Expanded access, which can provide access to investigational therapies when a patient does not qualify for a clinical trial, is sometimes available as well but must not interfere with clinical trials as it could delay availability of the approved treatment to the wider public. You can learn more about expanded access in our Expanded Access Navigator, which features guides for patients and caregivers, healthcare providers, and companies.
Use the link above to locate companies conducting COVID-19 research, learn about new and existing clinical trials, identify expanded access opportunities, and find trusted resources to guide you through this pandemic.
COVID-19 Evidence Accelerator
A collaboration of the Reagan-Udall Foundation for the FDA and Friends of Cancer Research, the Evidence Accelerator is an effort to accelerate the research community’s ability to coordinate the avalanche of real-world data being generated during this pandemic. The initiative brings together members of the health data community to share insights and compare results through weekly data-sharing meetings. In addition, the Accelerator will gather a core group of health systems, academic, government, technology, and data organizations, each working in parallel to co-design and execute real-world studies to answer critical questions about the diagnosis, treatment, and management of COVID-19.
On October 22, FDA approved remdesivir to be used for certain hospitalized patients with COVID-19. FDA has also issued several Emergency Use Authorizations (EUAs) for the use of monoclonal antibodies for the treatment of mild to moderate COVID-19 in adults (and some pediatric patients) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progressing to severe COVID-19 and/or hospitalization. All EUA letters of authorization and related information are available on the Drug and Biological Products Emergency Use Authorization page. Other antivirals are also being studied for the treatment or prevention of COVID-19.
Please visit our directory of companies investigating COVID-19 treatments for more information. And learn more about FDA’s efforts to facilitate COVID-19 therapeutic development through the Coronavirus Treatment Acceleration Program (CTAP).
Convalescent Plasma & Hyperimmune Globulin
One investigational treatment being explored for COVID-19 involves the use of convalescent plasma collected from recovered COVID-19 patients. It is possible that convalescent plasma that contains antibodies to SARS-CoV-2 might be effective against the infection.
Starting in April 2020, FDA facilitated a large expanded access treatment protocol sponsored by the Mayo Clinic for COVID-19 convalescent plasma for use in patients with serious or immediately life-threatening COVID-19 infections. This protocol ended, however, shortly after the FDA issued an emergency use authorization (EUA) for COVID-19 convalescent plasma for the treatment of hospitalized patients with COVID-19 on August 23, 2020. FDA has subsequently reissued this EUA with revisions. Furthermore, adequate and well-controlled randomized trials remain necessary for a definitive demonstration of COVID-19 convalescent plasma efficacy and to determine the optimal product attributes and appropriate patient populations for its use. Additional data will be forthcoming from other analyses and ongoing, well-controlled clinical trials. Read FDA’s guidance for industry on Investigational COVID-19 Convalescent Plasma.
FDA is also working with industry and government partners to facilitate the investigation, development, and availability of hyperimmune globulin as a potential treatment of COVID-19. Hyperimmune globulin is a biological product manufactured from convalescent plasma. The FDA is helping to coordinate a study of hyperimmune globulin that will be conducted by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health, as well as coordinating other efforts in this area.
Medical Devices for the COVID-19 Pandemic
The FDA is responsible for regulating medical devices used to diagnose, mitigate, prevent, and treat COVID-19, such as diagnostic tests, ventilators, and personal protective equipment (PPE)—including masks, face shields, respirators, gowns, and gloves. The FDA is committed to helping ensure that patients and health care providers have timely and continued access to high-quality diagnostic and therapeutic medical devices to respond effectively to the COVID-19 pandemic.