FDA Stakeholder Update - April 3, 2020

Announcements

April 2, 2020 - Daily Roundup April 2, 2020 - FDA Provides Updated Guidance to Address the Urgent Need for Blood During the Pandemic April 1, 2020 - Daily Roundup

Q&A for Consumers

The FDA is working to address the coronavirus disease (COVID-19) outbreak and keep you and your family informed on the latest developments. Here are the answers to some frequently asked questions from consumers about testing and treatments:

Q. How are people tested for COVID-19?

A. To be tested for COVID-19, a sample is typically collected from your nose and/or throat with a special swab at a designated collection location staffed by health care professionals. Currently, a health care professional swabbing the back of the nasal cavity through the nostril is the preferred choice. Alternatively, the health care professional could swab the back of your throat. Or for patients with symptoms of COVID-19, the sample could be collected by swabbing the inside of the front of the nose. Depending on, among other things, the type of swab used, a health care professional may collect the sample, or you may be able to collect the sample yourself at the collection site under the supervision of health care personnel.

Q: Are there any tests that I can purchase to test myself at home for COVID-19?

A: At this time, the FDA has not authorized any test that is available to purchase for testing yourself at home for COVID-19. The FDA sees the public health value in expanding the availability of COVID-19 testing through safe and accurate tests that may include home collection, and we are actively working with test developers on this goal. You can find listings of tests that have received an Emergency Use Authorization (EUA) as well as labs and manufacturers that have notified FDA as set forth in the FDA's Policy for Diagnostic Tests for Coronavirus Disease-2019.

Q: Should I take hydroxychloroquine or chloroquine to prevent or treat coronavirus or COVID-19 without a prescription?

A. No. Hydroxychloroquine and chloroquine are available in the United States by prescription only for the prevention or treatment of malaria and certain inflammatory conditions such as lupus. The FDA is working closely with other government agencies and academic centers to determine whether chloroquine can be used to prevent COVID-19 or treat patients with mild-to-moderate COVID-19. More information about the clinical trials studying these medicines can be found at ClinicalTrials.gov. 

To learn more about these and other coronavirus topics, visit: Frequently Asked Questions

Safely Using Hand Sanitizer

Each of us can help stop the spread of COVID-19 disease by washing our hands regularly with soap and water for 20 seconds – especially after going to the bathroom, before eating, and after coughing, sneezing, or blowing your nose. If soap and water are not available, the Centers for Disease Control and Prevention recommend that consumers use alcohol-based hand sanitizers containing at least 60% alcohol. The alcohol in hand sanitizer works best when you rub hand sanitizer all over your hands, making sure to get between your fingers and on the back of your hands. Do not wipe or rinse off the hand sanitizer before it is dry. Do not use hand sanitizer if your hands are visibly dirty or greasy; wash your hands with soap and water instead. [April 1, 2020]

Virtual Town Hall - 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 8, 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 15, 2020 from 12:15 PM – 1:15 PM ET 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 view the Town Hall details below. Town Hall Details Webinar: Enforcement Policy for Personal Protective Equipment (PPE) During COVID-19 The FDA will host a webinar for device manufacturers and industry to discuss and answer questions on the recently issued, immediately in effect guidances on enforcement policy for personal protective equipment (PPE) during COVID-19.  Date: Monday, April 6, 2020 Time: 3:00 PM - 4:00 PM ET No registration is required. You may view the webinar details below. PPE Webinar Details Guidance Documents and Request for Comments New Emergency Use Authorization (EUA) The FDA issued a new EUA specifically for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China. Under this EUA, authorized respirators listed in Appendix A are authorized for use in healthcare settings by healthcare personnel when used in accordance with CDC recommendations to prevent wearer exposure to pathogenic biological airborne particulates during FFR shortages resulting from the COVID-19 outbreak. [April 3, 2020] FDA Updates on Face Masks and Respirators During COVID-19: Enforcement Policy for Face Masks and Respirators (Revised) The FDA revised an immediately in effect guidance to provide a policy to help expand the availability of general use face masks for the general public and particulate filtering facepiece respirators (including N95 and KN95 respirators) for health care professionals during this pandemic.  This guidance updates the previous version of the guidance published on March 25, 2020.  This update provides recommendations regarding face shields, surgical masks, and alternatives, which may include KN95 respirators, when FDA-cleared or NIOSH-approved N95 respirators are not available. [April 2, 2020] Submit Comments

Temporary Policy Regarding Nutrition Labeling of Standard Menu Items in Chain Restaurants and Similar Retail Food Establishments During the COVID-19 Public Health Emergency The FDA is issuing this guidance to chain restaurants and similar retail food establishments that sell standard menu items[1] covered under the menu labeling provisions of section 403(q)(5)(H) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to provide flexibility regarding these menu labeling requirements during the COVID-19 pandemic. As a result of the COVID-19 pandemic, the FDA released a guidance document to provide temporary flexibility to chain restaurants and similar retail food establishments currently required to provide nutrition information, including calories, on menus and menu boards. [April 1, 2020] Submit Comments

Safety Information

FDA Requests Removal of All Ranitidine Products (Zantac) from the Market The FDA announced it is requesting manufacturers withdraw all prescription and over-the-counter (OTC) ranitidine drugs from the market immediately. This is the latest step in an ongoing investigation of a contaminant known as N-Nitrosodimethylamine (NDMA) in ranitidine medications (commonly known by the brand name Zantac). The agency has determined that the impurity in some ranitidine products increases over time and when stored at higher than room temperatures and may result in consumer exposure to unacceptable levels of this impurity. As a result of this immediate market withdrawal request, ranitidine products will not be available for new or existing prescriptions or OTC use in the U.S. [April 1, 2020]

Consumer Updates Cooperative Agreement to Support an Evidence-based Clinical Practice Guideline for the Treatment of Acute Dental Pain The FDA is pleased to announce the funding opportunity, “Cooperative Agreement to Support an Evidence-based Clinical Practice Guideline for the Treatment of Acute Dental Pain.” FDA seeks applications to develop, disseminate, implement, and evaluate, an evidence-based Clinical Practice Guideline (CPG) for the treatment of acute dental pain (surgical and non-surgical). Applicants are asked to propose a comprehensive evidence-based plan that advances appropriate prescribing of opioid analgesics for patients with acute dental pain. Please keep in mind the following key dates: Letter of Intent Due Date: April 20, 2020 Application Due Date: June 1, 2020 Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date. For more information, the RFA may be accessed below. Alternatively you can search www.grants.gov for RFA-FD-20-029.

Access RFA   Search Grants

FDA Voices

FDA Commissioned Corps Officers on the Front Line of COVID-19 Response

By: Stephen M. Hahn, M.D., Commissioner of Food and Drugs During this difficult time when everyday life is disrupted, classes are cancelled and work hours are cut for many around the country, we are all pulling together to do what we can to #FlattenTheCurve—to slow the spread of the coronavirus in the U.S. Social distancing and the manner in which it changes our way-of-life is not easy, but alongside other public health practices like washing our hands and covering our coughs, social distancing can actually save lives. Not only does staying at home help protect older people and those with compromised immune systems, it also helps protect the people in our community who are on the front lines of this battle—first responders and health care workers. These are the workers who are essential, who cannot stay home, and who are providing critical care for loved ones and community members. [April 2, 2020]