Coronavirus (COVID-19) FDA Update : New Policy for Hand Sanitizers and Diagnostics

Product Id : FDS237
Instructor : Norma Skolnik
Apr 28, 2020 1:00 PM ET | 12:00 PM CT | 10:00 AM PT | 60 Minutes

Description

The webinar will cover FDA’s new policy  for certain laboratories that develop and begin to use validated COVID-19 diagnostics before the FDA has completed review of their Emergency Use Authorization (EUA) requests. As part of the U.S. Food and Drug Administration’s ongoing commitment to address the coronavirus (COVID-19) pandemic, the agency has issued two guidance documents to communicate its policy for the temporary manufacture of certain alcohol-based hand sanitizer products. These guidance documents will be in effect for the duration of the public health emergency declared by the Secretary of Health and Human Services (HHS) on January 31, 2020.

The agency lacks information on the methods being used to prepare such products and whether they are safe for use on human skin. The guidance Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19), is immediately in effect and outlines that the agency does not intend to take action against manufacturing firms that prepare alcohol-based hand sanitizers for consumer use and for use as health care personnel hand rubs during this ongoing public health emergency as described in the guidance . The second guidance, Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency, is in effect for the temporary compounding of certain alcohol-based hand sanitizers by pharmacists in state-licensed pharmacies or federal facilities and registered outsourcing facilities.

Learning Objectives:

  • Public Health Coronavirus crisis in U.S. Status
  • Guidelines on new Hand Sanitizers
  • What should be mixed and what percentage of Alcohol should be kept
  • Background on U.S. Coronavirus needs for Diagnostic Testing
  • FDA’s new policy to Expedite Availability of Diagnostics & Diagnostic Testing
  • How laboratories can develop and begin to use validated COVID-19 diagnostics before FDA completes 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
Speaker Profile:

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


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