The webinar will cover the FDA’s new policy for certain laboratories that develop and begin to use validated COVID-19 diagnostics before the FDA has completed a review of their Emergency Use Authorization (EUA) requests. The FDA can issue a EUA to permit the use, based on scientific data, of certain medical products that may be effective in diagnosing, treating or preventing a disease or condition when there is a determination, by HHS, that there is a public health emergency or significant potential for a public health emergency.

The audience will be benefited by learning how laboratories can develop and begin to use validated COVID-19 diagnostics before the FDA has completed a review of their Emergency Use Authorization (EUA) requests. The FDA can issue a EUA to permit the use, based on scientific data, of certain medical products that may be effective in diagnosing, treating or preventing a disease or condition when there is a determination, by HHS, that there is a public health emergency or significant potential for a public health emergency like the Corona Virus.

Learning Objectives:-

• Public Health Coronavirus crisis in U.S. Status
• Background on U.S. Coronavirus needs for Diagnostic Testing
• FDA’s new policy to Expedite Availability of Diagnostics & Diagnostic Testing
• Emergency Use authorization for COVID-19 Diagnostics
• How laboratories can develop and begin to use validated COVID-19 diagnostics before FDA completes a review of their Emergency Use Authorization.

Who Will Benefit:-

• U.S. Diagnostics laboratory managers and directors
• Testing laboratory managers and Quality Assurance staff
• Pharmaceutical Company Regulatory Affairs managers and directors