The webinar will cover the FDA’s new policy for laboratories that develop and begin to use validated COVID-19 diagnostics before the FDA has completed 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’s a determination, by HHS, that there is a public health emergency. The webinar will also cover the FDA’s new policy on the manufacture of Hand Sanitizers to respond to the Coronavirus crisis.

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 use validated COVID-19 diagnostics before FDA completes a review of their Emergency Use Authorization.
• FDA’s new policy on the manufacture of Hand Sanitizers in response to the COVID 19 crisis.

Why Should You Attend?

The audience will benefit 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. Companies that want to manufacture hand sanitizers according to new FDA standards will also greatly benefit from this presentation.

Who Will Benefit:-

• Consumer Healthcare companies
• Pharmaceutical Company Regulatory Affairs managers and directors
• Testing laboratory managers and Quality Assurance staff
• U.S. Diagnostics laboratory managers and directors
• Manufacturers of Hand Sanitizers