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  1. Emergency Preparedness | Drugs

Coronavirus (COVID-19) | Drugs

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In response to the novel coronavirus (COVID-19), FDA quickly created, in March 2020, the Coronavirus Treatment Acceleration Program (CTAP), which was designed to help facilitate the development of drugs and biological products (other than vaccines) for COVID-19 therapeutics. The development of COVID-19 therapeutics that are effective against current and future variants remains a critical priority. CTAP is leveraging the agency’s scientific experience and knowledge of COVID-19 to support current and future clinical trials testing new treatments for COVID-19. From these efforts, we continue to gain valuable knowledge about the safety and effectiveness of potential therapies for COVID-19.

COVID-19 Therapeutics

When FDA approves a drug, it means the agency has determined, among other things, that:

  • The drug is safe and effective for its intended use;
  • The benefits of the drug outweigh its risks when used according to its approved labeling;
  • The drug’s labeling (including the package insert) is appropriate; and
  • The methods used in manufacturing the drug and the controls used to maintain the drug’s quality are adequate to preserve the drug’s identity, strength, quality and purity.

The statutory standard for an FDA-approval requires substantial evidence of effectiveness, which is a different level of evidence of effectiveness than required for an EUA.

Under section 564 of the Federal Food, Drug & Cosmetic Act (FD&C Act), FDA may, pursuant to a determination and declaration by the Secretary of the Department of Health and Human Services (HHS), authorize an unapproved product or unapproved uses of an approved product for emergency use. In issuing an EUA, FDA must determine, among other things, that:

  • Based on the totality of scientific evidence available-
    • The product may be effective in diagnosing, treating, or preventing a serious or life-threatening disease or condition caused by a chemical, biological, radiological, or nuclear agent;
    • That the known and potential benefits of the product, when used to diagnose, prevent or treat such disease or condition, outweigh the known and potential risks of the product; and
  • That there are no adequate, approved, and available alternatives to the product for diagnosing, preventing, or treating such disease or condition.

FDA may revise or revoke EUAs at any time, for example, when the drug receives FDA-approval and such product is sufficiently available to meet the public health demand, or when revision or revocation is appropriate to protect the public health or safety.

FDA’s EUA page has information about vaccine and therapeutic products currently authorized under an EUA, as well as the current product fact sheets and additional information for health care professionals and patients. FDA and Health and Human Services Administration for Strategic Preparedness and Response have announced extensions to the shelf life for some EUA products. Find these updates on FDA’s Expiration Dating Extension page.

Learn more about EUAs in this video.
Read more about COVID-19 regulatory terminology on the FDA website.

  • Antiviral Drugs
    Antiviral drugs are medicines (pills, liquid, an inhaled powder, or an intravenous solution) that fight against viruses in your body.
  • Immune Modulators
    Immune modulators are medicines that help activate, boost, or suppress the immune function. In the case of COVID-19 infection, the immune system can become hyperactive which may result in worsening of disease. Immune modulators can help suppress this hyperinflammation.
  • Monoclonal Antibodies (mAbs) targeting SARS-COV-2
    SARS-COV-2-targeting mAbs are laboratory-produced antibodies that can help the immune system's attack on SARS-COV-2. These mAbs block entry of SARS-CoV-2 into human cells, thus neutralizing the virus. SARS-CoV-2 can mutate over time, resulting in genetic variation in the population of circulating viral strains. Some variants can cause resistance to one or more of the mAb therapies authorized to treat COVID-19.
  • Renal Replacement Therapy Solutions
    Continuous renal replacement therapy (CRRT) is a type of “dialysis,” which is a machine treatment that filters and purifies the blood when a patient’s kidneys are damaged or are not functioning normally. CRRT is used for patients with kidney injury in acute care settings. SARS-CoV-2 led to an increased population with critical illness and multiple organ failure, including acute kidney injury, increasing the need for CRRT. In addition, there was an insufficient supply of replacement solutions to meet the emergency need to provide CRRT in critically ill patients.


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Additional Resources

Additional Resources

COVID-19 Treatment Hub

Provides physicians, patients, and caregivers with information about the latest research in the fight against COVID-19

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