COVID 19: FDA New Regulatory Policies in Response to the Virus

Recorded Webinar | Norma Skolnik | From: Nov 05, 2020 - To: Dec 31, 2020

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COVID-19 Crisis: FDA New Diagnostic Test Policy, Emergency Use Authorization &  New Hand Sanitizer Guidance Response

The webinar will cover the FDA response to the Corona Virus outbreak in 3 areas: FDA’s new policy to Expedite Availability of Diagnostic Testing and new Guidance on the manufacture of alcohol-based hand sanitizers. The specific requirements for laboratories to produce diagnostic tests and for non-traditional drug firms to manufacture hand sanitizers under FDA enforcement discretion will be reviewed.  Emergency Use Authorizations in response to Covid 19 will also be covered.

This session will help companies who want to start producing diagnostic tests and hand sanitizers in response to the Corona Virus/Covid 19 epidemic in the U.S. 

Learning Objectives:-

  • FDA’s New Policy to Expedite the Availability of Diagnostic Tests 
  • How certain laboratories can develop and start to use validated COVID 19 diagnostics before FDA completes a EUA review.
  • Emergency Use Authorization for drugs to treat Covid 19.
  • Criteria for which laboratories can use the new policy to respond to the Corona Virus crisis
  • FDA New Guidance documents for the emergency manufacture of Hand Sanitizers
  • FDA’s Specific Requirements for the manufacture of alcohol-based hand sanitizers 
  • Enforcement discretion for alcohol-based hand sanitizer manufacturers who meet FDA standards

Who Will Benefit:-

  • Regulatory Affairs directors
  • managers and associates
  • Quality Assurance managers
  • Marketing and Business managers
  • Attorneys who work with diagnostic tests and hand sanitizer manufacture and marketing. Laboratories that manufacture test kits.

Norma Skolnik

Norma Skolnik has over 35 years of regulatory experience working with the pharmaceutical and dietary supplement industries. She served as Director of Regulatory Affairs for the Americas for Cadbury Adams. Prior to that, she was Director of Regulatory Affairs for the Adams Division of Pfizer and Associate Director of Regulatory Affairs for the Warner-Lambert company.

She also served as Director of Regulatory Affairs for Lederle Consumer Healthcare, as Associate Director of Marketed Product Support for Lederle Laboratories and as Associate Director of Regulatory Affairs for Wyeth.

Norma currently works as a regulatory consultant and also enjoys coaching those who are just starting out in the consulting field