FDA Stakeholder Update - April 10, 2020

Announcements

April 10, 2020 - FDA Letter to Stakeholders: Do Not Use Ivermectin Intended for Animals as Treatment for COVID-19 in Humans April 10, 2020 - FDA Authorizes Blood Purification Device to Treat COVID-19 April 9, 2020 - Daily Roundup April 8, 2020 - FDA Warns Seller Marketing Dangerous Chlorine Dioxide Products that Claim to Treat or Prevent COVID-19 April 8, 2020 - Daily Roundup April 7, 2020 - Serological Tests April 7, 2020 - Daily Roundup April 6, 2020 - Daily Roundup April 3, 2020 - FDA Coordinates National Effort to Develop Blood-Related Therapies for COVID-19

FDA released a new webpage of information to help address questions patients and caregivers may have about FDA-regulated medical products (drugs, biologics, and devices) during the coronavirus (COVID-19) outbreak. The webpage is a source of information for patients during this time of crisis.

Visit Webpage

Webinars and Virtual Workshops Virtual Town Hall Series - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests The FDA will host a virtual Town Hall for clinical laboratories and commercial manufacturers that are developing or have developed diagnostic tests for SARS-CoV-2. The purpose of this Town Hall is to help answer technical questions about the development and validation of tests for SARS-CoV-2. Date: Wednesday, April 15, 2020 Time: 12:15 PM – 1:15 PM ET The FDA also plans to hold virtual Town Halls for clinical laboratories and commercial manufacturers to help answer questions on the following dates:   April 22, 2020 from 12:15 PM – 1:15 PM ET April 29, 2020 from 12:15 PM – 1:15 PM ET No registration is required. You may access the Town Hall details below Town Hall Details

Fiscal Year (FY) 2020 Generic Drug User Fee Amendments (GDUFA) Regulatory Science Initiatives Virtual Public Workshop FDA will hold a science-focused Public Workshop to provide an overview of the status of the current FY 2020 Generic Drug User Fee Amendments (GDUFA) Science and Research Priorities as well as solicit input on the development of next year’s (FY 2021) priorities. The workshop will be offered via WebEx for all participants. Date: Wednesday, May 4, 2020 Time: 8:30 AM - 4:30 PM ET For more details about this Workshop, please visit the meeting page. Workshop Details

Guidance Documents

Temporary Policy Regarding Non-Standard PPE Practices for Sterile Compounding by Pharmacy Compounders not Registered as Outsourcing Facilities During the COVID-19 Public Health Emergency FDA is issuing this guidance to communicate its temporary policy related to PPE use during human drug compounding , at State-licensed pharmacies or Federal facilities that are not registered with FDA as outsourcing facilities (referred to collectively in this guidance as compounders). Policy for the Temporary Use of Portable Cryogenic Containers Not in Compliance With 21 CFR 211.94(e)(1) For Oxygen and Nitrogen During the COVID-19 Public Health Emergency Guidance for Industry FDA is issuing this guidance to communicate its policy for the temporary use of certain gas containers for oxygen and nitrogen intended for medical use for the duration of the public health emergency declared by the Secretary of Health and Human Services (HHS) on January 31, 2020. Investigational COVID-19 Convalescent Plasma FDA is issuing this guidance to provide recommendations to health care providers and investigators on the administration and study of investigational convalescent plasma collected from individuals who have recovered from COVID-19 (COVID-19 convalescent plasma) during the public health emergency.  The guidance also provides recommendations to blood establishments on the collection of COVID-19 convalescent plasma.

For a more comprehensive list of all official FDA Guidance Documents and other regulatory guidances, please visit here.

FDA Voices

A Perspective on the FDA’s COVID-19 Response

By: Mitch Zeller, Director, FDA Center for Tobacco Products I have the honor to run the FDA’s Center for Tobacco Products (CTP). While CTP’s work to protect the public health is essential and continues during the pandemic, we are the least involved of the FDA centers when it comes to working directly on the coronavirus (COVID-19) response. That said, I’ve been proud to join my FDA colleagues in our “all-hands-on-deck” approach to tackling this pandemic, lending as much support as possible as my FDA colleagues across the entire organization work tirelessly for the American people.  The COVID-19 pandemic represents a new and significant challenge for all of us – both personally and professionally. Despite these challenges and the impact on all of us, I am hopeful and inspired by what I see happening behind the scenes at the agency. [April 10, 2020]