US FDA Grants Emergency Authorization for Remdesivir (Download PDF)

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US FDA Grants Emergency Authorization for Remdesivir

  • The emergency use authorization (EUA) has been granted to remdesivir by United States FDA (Food and Drug Administration) for patients of COVID-19.

  • Remdesivir is an anti-viral drug.

  • US based Gilead Sciences Inc. (Biopharmaceutical Company) has developed the broad-spectrum antiviral medication.

US FDA grants emergency authorization for remdesivir

US FDA grants emergency authorization for remdesivir

Overview

  • In addition to open trial of the drug sponsored by Gilead Sciences, NIAID (National institute of Allergy and Infectious Diseases) also conducted a review of top line data from double-blinded, randomized, placebo controlled trial of remdesivir.

  • The drug will be administered intravenously in the hospitals.

  • Any adverse event will be report by Gilead Sciences to FDA.

  • The EUA given by FDA allows for distribution and emergency use of the drug for COVID-19 patients only.

  • However, approval of any product is not guaranteed by EUA given by FDA.

  • FDA has not approved remdesivir and it still remains an investigational drug.

  • Under section 564 of the Federal Food, Drug and Cosmetic Act (FD & C Act), ‘unapproved’ medical products can be allowed by FDA commissioner for use in

    • Emergency diagnosis

    • Treatment

    • Prevention of a serious or life threatening disease/condition.

  • The act includes conditions in which threat is caused by chemical, biological, radiological and nuclear Defence agents.

  • The declaration of health emergency by the US Health and Human services (HHS) secretary, for which there is no approved drug, is necessary for such authorization by FDA.

  • As the HHS declares that emergency is over, the EUA declaration is also terminated.

  • If the status of drug changes to ‘approved’, the EUA declaration is also terminated.

  • If the known potential benefits of product outweigh the risks (known and potential), then the drug may be considered by commissioner for EUA.

  • The drug producer needs to come up with detailed information with a fact sheet (containing usage and potential harmful effects), for healthcare professionals.

- Published/Last Modified on: August 9, 2020

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