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  • Regulatory NewsRegulatory News

    FDA authorizes first COVID test via traditional review pathway

    The US Food and Drug Administration (FDA) on Wednesday authorized the first diagnostic for COVID-19 using a traditional review process, paving the way for more tests to gain clearance through the agency’s 510(k) pathway.   After authorizing hundreds of SARS-CoV-2 diagnostics under emergency use authorizations (EUAs), FDA has authorized the BioFire Respiratory Panel 2.1 (RP2.1) for the simultaneous detection and identification of multiple respiratory viral and bacterial...
  • Regulatory NewsRegulatory News

    FDA Authorizes Use of New, Substantially Faster Ebola Diagnostic Tests

    The US Food and Drug Administration (FDA) has granted emergency use authorizations (EUAs) to two new diagnostic tests meant to help health professionals to accurately diagnose the Ebola Zaire virus in record time. Background In March 2013, FDA was given a host of new authorities and responsibilities under the  Pandemic and All-Hazards Preparedness Reauthorization Act  ( PAHPRA ), a piece of legislation intended to bolster the government's ability to respond to health ...