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U.S. FDA

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22 Oct, 5 tweets, 2 min read

Today, we gave the first FDA approval for a #COVID19 treatment. The drug was approved for adults and children ages 12 and older for the treatment of #COVID19 requiring hospitalization. fda.gov/news-events/pr…

This approval does not include the entire population that had been authorized to use the drug under an Emergency Use Authorization (EUA). An approval is different from the standard used for an EUA.

While children younger than 12 are not covered in this approval, children under 12 weighing at least 3.5 kg (about 8 pounds) are covered in a revised EUA for the drug.

This approval was supported by our analysis of data from three randomized, controlled clinical trials that included patients hospitalized with mild-to-severe #COVID19.

We are committed to expediting the development and availability of treatments during this pandemic, including for pediatric patients.

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Here’s a look at some of the FDA’s latest activities in our ongoing response to the #COVID19 pandemic. fda.gov/news-events/pr…

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15 Aug

@Yale

Today, we issued an emergency use authorization to @Yale for its SalivaDirect #COVID19 diagnostic test, which uses a new method of processing saliva samples. This is the 5th test FDA has authorized using saliva as a sample for testing. fda.gov/news-events/pr…

With this test, a saliva sample can be collected in any sterile container. The test doesn’t need a special swab or collection device, or a separate nucleic acid extraction step.

Being able to perform a test without extraction kits can increase testing capacity and reduce the strain on resources. Also, the test can be used more broadly with different combinations of commonly used reagents and instruments.

Read 4 tweets

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