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 there are no drugs, therapeutics, or vaccines yet approved to specifically treat, cure, or prevent COVID-19, there are options —from enrolling in clinical trials to 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 links 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 will bring 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 treatment and management of COVID-19.
Anti-Malaria & Other Anti-viral Drugs
Some approved medications are being studied to treat COVID-19 and are being made available under special circumstances. For example, chloroquine and hydroxychloroquine, drugs already approved for treating malaria and other conditions, are being tested to determine whether these can be used to treat patients with COVID-19. On May 1, FDA issued an Emergency Use Authorization to allow remdesivir to be used for certain patients with severe COVID-19. In April, FDA issued a Drug Safety Communication cautioning against the use of hydroxychloroquine or chloroquine for COVID-19 outside of the hospital setting or a clinical trial due to risk of heart rhythm problems. You can find more information about hydroxychloroquine and remdesivir, including fact sheets for healthcare providers and patients, here.
Other antivirals are also being studied for efficacy in the treatment of COVID-19. Please visit our directory of companies investigating COVID-19 treatments for more information. Learn more about FDA’s efforts to facilitate development here.
Investigational COVID-19 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 convalescent plasma that contains antibodies to SARS-CoV-2 might be effective against the infection.
FDA is facilitating expanded access to COVID-19 convalescent plasma for use in patients with serious or immediately life-threatening COVID-19 infections. The initial effort focused on emergency Investigational New Drug Applications (eINDs) for individual patients under 21 CFR 312.310. FDA is also helping to facilitate a collaborative effort with industry, academic, and government partners to implement a protocol for the use of convalescent plasma for patients in need across the country who may not have access to institutions with clinical trials in place. This does not include the use of COVID-19 convalescent plasma for the prevention of infection. Read FDA’s Guidance for Industry on Investigational COVID-19 Convalescent Plasma, and learn more here and here.
FDA is also working with industry and government partners to accelerate the development and availability of hyperimmune globulin for investigation for the potential treatment 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, 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 ensuring 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.