From July to September, eight Chinese in vitro diagnostic companies have successively obtained Emergency Use Authorization(EUA) issued by US Food and Drug Administration (FDA) .
FDA will not require developers to submit a premarket approval application, premarket notification or emergency use authorization for laboratory developed tests, the Department of Health and Human Services announced on August 19th.
The U.S. Food and Drug Administration issued an emergency use authorization (EUA) for investigational convalescent plasma for the treatment of COVID-19 in hospitalized patients as part of the agency’s ongoing efforts to fight COVID-19.
The American Red Cross has begun testing all blood, platelet and plasma donations for COVID-19 antibodies.
P23 Labs has received Emergency Use Authorization for its coronavirus PCR test from the US Food and Drug Administration.
The US Food and Drug Administration on Thursday granted separate Emergency Use Authorizations (EUAs) for PCR-based SARS-CoV-2 tests developed by South Korean diagnostic test makers BioCore, SolGent, and Seasun Biomaterials.
The US Food and Drug Administration on Wednesday announced the approval of AstraZeneca and Merck's olaparib (Lynparza) for metastatic castration-resistant prostate cancer patients with homologous recombination repair deficiency.
P23 Labs has received Emergency Use Authorization for its coronavirus PCR test from the US Food and Drug Administration.
The US Food and Drug Administration on Thursday granted separate Emergency Use Authorizations (EUAs) for PCR-based SARS-CoV-2 tests developed by South Korean diagnostic test makers BioCore, SolGent, and Seasun Biomaterials.
Grifols Diagnostic Solutions announced Thursday its Procelix Panther System featuring Automation Ready Technology (ART) received approval from the US Food and Drug Administration.
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