The ID Pipeline: FDA Activity From the Week of March 8, 2020
Here is a look at infectious disease-related US Food and Drug Administration (FDA) news from the week of March 8, 2020.
Here is a look at infectious disease-related US Food and Drug Administration (FDA) news from the week of March 8, 2020.
FDA Issues Emergency Use Authoriszation for Cobas SARS-CoV-2 Test
The US Food and Drug Administration (FDA) has granted Emergency Use Authorization for the cobas SARS-CoV-2 test. The test, produced by Roche, is used to detect SARS-CoV-2 in oropharyngeal and nasopharyngeal swab samples.
In light of the urgent medical need for testing, it is noteworthy that the test can be run on existing automated cobas 6800 and cobas 8800 analyzer systems which are available throughout the United States.
“Providing quality, high-volume testing capabilities will allow us to respond effectively to what the World Health Organization has characterized as a pandemic,” Thomas Schinecker, CEO of Roche Diagnostics, said in a press release.
This is one of several diagnostics granted Emergency Use Authorization during the outbreak.
Read the full article here.
Paratek Submits pre-Emergency Use Authorization Application to FDA for Omadacycline
Paratek Pharmaceuticals has submitted a pre-Emergency Use Authorization application for omadacyline.
If the authorization is granted, the FDA could allow for the use of the antibiotics during a declared emergency for treatment and prophylaxis of pulmonary anthrax in a health emergency.
The authorization request was submitted by the Biomedical Advanced Research and Development Authority (BARDA) as part of a public-private partnership between Paratek and BARDA.
Read the full press release here.
