FDA’s Center for Biologics Evaluation and Research (CBER) uses every tool available to help patients access promising biological products while facilitating research to evaluate their safety and efficacy as well as manufacturing efforts.
CBER is working on multiple fronts to address the COVID-19 pandemic, including:
- Expediting clinical trials for vaccines and certain therapeutic biological products that hold promise to prevent or treat COVID-19 by providing timely interactions, scientific advice, and recommendations for specific sponsors, and generally through guidance documents;
- Supporting product development and facilitating the scaling up of manufacturing capacity for high priority products to treat COVID-19;
- Expediting the review of Emergency Use Authorization (EUA) requests and Biologics License Applications (BLAs) for critical medical products to address COVID-19;
- Helping to ensure an adequate and safe blood supply; and
- Providing information to healthcare providers and researchers to help them submit expanded access IND requests to permit the use of investigational products for patients with COVID-19.
FDA has approved one drug to treat COVID-19 and eleven therapeutics are currently authorized for emergency use. For example, the Agency has issued three EUAs to authorize the emergency use of certain therapeutic products intended to treat serious or life-threatening diseases or conditions (e.g., Acute Kidney Injury, Acute Respiratory Distress Syndrome) caused by COVID-19 after determining that the FDA-approved alternatives to these products were not available in sufficient quantities to fully meet the emergency need. This has helped to alleviate shortages of some therapies that are essential for the care of critically ill COVID-19 patients.
In addition, the Agency has prioritized the review of generic drug applications for potential treatments and supportive therapies for patients with COVID-19, such as antibiotics, sedatives used in ventilated patients, anticoagulants, and pulmonary medications.
