Food and Drug Administration coronavirus update: June 8, 2020

June 8, 2020

The following is a press release from the U.S. Food and Drug Administration:

The U.S. Food and Drug Administration today continued to take action in the ongoing response to the COVID-19 pandemic:

  • The FDA issued a guidance, titled “Temporary Policy on Prescription Drug Marketing Act Requirements for Distribution of Drug Samples During the COVID-19 Public Health Emergency.” The guidance addresses questions FDA has received concerning prescription drug sample distribution under the Prescription Drug Marketing Act of 1987 (PDMA) during the COVID-19 public health emergency. The guidance explains that, on a temporary basis, the FDA does not intend to object to the delivery of prescription drug samples to patients’ homes if requested by their licensed health care professional, and the guidance describes the agency’s current policy regarding the signature required at time of delivery of drug samples, to promote public health.
  • On June 8, 2020, the FDA added the BioMedInnovations SuppleVent Ventilator to the list of ventilators authorized under the March 24, 2020, EUA for certain ventilators, ventilator tubing connectors, and ventilator accessories. This ventilator provides continuous ventilatory support for adult patients who require mechanical ventilation. The ventilator is intended for institutional use by qualified, trained personnel under the direction of a doctor. Institutional use includes use in an intensive care unit or other hospital environments such as during intra-hospital transport and in temporary hospital facilities. Lawrence Livermore National Laboratory collaborated in the design of the ventilator.
  • FDA published two new web pages to help the public access information: (1) Innovation to Respond to COVID-19 provides an overview of FDA’s innovative approaches to respond to COVID-19 as quickly and safely as possible and (2) Educational Resources provides links to FDA-produced COVID-19-related resources that help explain FDA’s work.
  • Testing updates:
    • To date, the FDA has authorized 125 tests under EUAs, which include 107 molecular tests, 17 antibody tests, and 1 antigen test.

Additional Resources:

Consumer Inquiries: 888-INFO-FDA

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Food and Drug Administration coronavirus update: June 2, 2020

June 2, 2020

The following is a press release from the U.S. Food and Drug Administration:

The U.S. Food and Drug Administration today continued to take action in the ongoing response to the COVID-19 pandemic:

  • The agency issued a new FDA Voices, titled Pandemic Challenges Highlight the Importance of the New Era of Smarter Food Safety, and bylined by Stephen M. Hahn, M.D., Commissioner of Food and Drugs, and Frank Yiannas, Deputy Commissioner for Food Policy and Response. In March, the FDA was a few days away from announcing the release of the New Era of Smarter Food Safety Blueprint when the FDA’s focus turned to the COVID-19 pandemic. Plans for the New Era initiative were rightfully put on hold in order to prioritize the agency’s COVID-19 response. The FDA will release the blueprint in the coming weeks, outlining plans over the next decade to create a more digital, traceable, and safer food system.
  • The FDA published guidance, titled Institutional Review Board (IRB) Review of Individual Patient Expanded Access Requests for Investigational Drugs and Biological Products During the COVID-19 Public Health Emergency Guidance for IRBs and Clinical Investigators, which includes recommendations regarding procedures for single IRB member review. This is in response to physician requests for a waiver from the requirement for full IRB review. The guidance recommendations also address factors to consider when assessing potential benefits and risks for a particular patient being treated under expanded access.
  • The FDA added a second ventilator developed by NASA to the list of authorized ventilators, ventilator tubing connectors and ventilator accessories under the ventilator emergency use authorization (EUA) that was issued in response to concerns relating to insufficient supply and availability of FDA-cleared ventilators for use in health care settings to treat patients during the COVID-19 pandemic. The NASA VITAL (Ventilator Intervention Technology Accessible Locally) is intended to last three to four months and is specifically tailored to provide respiratory support for COVID-19 patients who are experiencing respiratory failure or insufficiency. Where the first NASA ventilator relied on wall gas as the pressure source, the second ventilator uses an internal compressor for its energy source. The device is designed to be built with components outside the current medical device supply chain and therefore does not impact the existing supply chain of currently made ventilators.
  • The FDA added an emergency resuscitator for the Fitbit Flow to the list of authorized ventilators, ventilator tubing connectors and ventilator accessories under the ventilator emergency use authorization (EUA). The Fitbit Flow is a continuous respiratory support system that includes an FDA-cleared Manual Resuscitator. The accessory is an AMBU bag with audible and visual alarms that aid the performance of the manual resuscitator for continuous breathing. This design is intended for use in treating patients with COVID-19.
  • The FDA, in collaboration with the European Medicines Agency (EMA), provided procedural assistance to sponsors and applicants who anticipate submission of pediatric product development plans for the treatment and prevention of COVID-19. In issuing this Common Commentary, the FDA and EMA aspire to streamline administrative processes and facilitate efficient submission of an initial Pediatric Study Plan (iPSP) and Paediatric Investigation Plan (PIP).
  • The FDA recognizes the vital role of health professionals in the fight against COVID-19. In order to help health professionals quickly and easily access FDA resources, we created a new web page, titled Coronavirus Disease 2019 (COVID-19) Resources for Health Professionals. This page contains links to FDA emergency use authorizations; information about personal protective equipment and other medical products for use during COVID-19.
  • Testing updates:
    • During the COVID-19 pandemic, the FDA has worked with more than 400 test developers who have already submitted, or said they will be submitting, EUA requests to the FDA for tests that detect the virus or antibodies to the virus.
    • To date, the FDA has authorized 119 tests under EUAs, which include 103 molecular tests, 15 antibody tests, and 1 antigen test.

Additional Resources:

Consumer Inquiries: 888-INFO-FDA

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Food and Drug Administration coronavirus update: May 29, 2020

May 29, 2020

The following is a press release from the U.S. Food and Drug Administration:

The U.S. Food and Drug Administration today continued to take action in the ongoing response to the COVID-19 pandemic:

  • FDA is making its previously developed FDA MyStudies app available to investigators as a free platform to securely obtain patients’ informed consent for eligible clinical trials when face-to-face contact is not possible or practical due to COVID-19 control measures. FDA MyStudies is now referred to as COVID MyStudies in the Apple App store and in the Google Play store.
  • As part of the FDA’s efforts to protect consumers, the agency issued warning letters to two companies for selling fraudulent COVID-19 products. There are currently no FDA-approved products to prevent or treat COVID-19. Consumers concerned about COVID-19 should consult with their health care provider.
    • The first seller to whom FDA sent a warning letter was Quadrant Sales & Marketing, Inc., which offers non-alcohol-based hand sanitizer products for sale in the United States with false or misleading claims including that the products maintain their effectiveness for up to 24 hours. Time-specific extended efficacy claims may give users the false impression that they need not rigorously adhere to interventions such as social distancing and engaging in good hygienic practices that have been demonstrated to curb the spread of COVID-19.
    • The second seller to whom FDA sent a warning letter was StayWell Copper Products, which offers copper “Germ Stopper” products for sale in the United States with misleading claims that the products are safe and/or effective for the prevention  of COVID-19.
  • Today, the FDA took steps to further support the development of COVID-19 tests for at-home self-collection by providing on its website a template that may be used to facilitate submission of requests for emergency use authorizations (EUA) for at-home sample collection kits. As explained in FDA’s guidance, Policy for COVID-19 Tests During the Public Health Emergency (Revised), this template reflects FDA’s current thinking on the data and information that developers should submit to facilitate the EUA process. In particular, this template includes recommendations for use by laboratories and commercial manufacturers who may choose to use it to facilitate the preparation and submission of an EUA request. Currently, developers can offer a COVID-19 test for at-home self-collection where specifically authorized under an EUA or as part of an Institutional Review Board (IRB)-approved study.
  • Testing updates:
    • During the COVID-19 pandemic, the FDA has worked with more than 400 test developers who have already submitted, or said they will be submitting, EUA requests to the FDA for tests that detect the virus or antibodies to the virus.
    • To date, the FDA has authorized 114 tests under EUAs, which include 101 molecular tests, 12 antibody tests, and 1 antigen test.

Additional Resources:

Food and Drug Administration coronavirus update: May 18, 2020

May 18, 2020

The following is a press release from the U.S. Food and Drug Administration:

The U.S. Food and Drug Administration today continued to take action in the ongoing response effort to the COVID-19 pandemic:

  • The FDA issued warning letters to two companies for selling fraudulent COVID-19 products, as part of the agency’s effort to protect consumers. There are currently no FDA-approved products to prevent or treat COVID-19. Consumers concerned about COVID-19 should consult with their health care provider.
    • The first seller warned, Noetic Nutraceuticals, offers CBD products for sale in the U.S. with misleading claims that the products are safe and/or effective for the prevention and treatment of COVID-19.
    • The second seller warned, The Golden Road Kratom, offers kratom products for sale in the U.S. with misleading claims that the products are safe and/or effective for the prevention and treatment of COVID-19.
  • The Agency issued a new FDA Voices titled, COVID-19 Supply Chain Update: Importation of Vital Food and Medical Products. It provides details on the FDA’s work to ensure the safety and security of the U.S. supply of food and medical products. Many of the medical products our health care workers and hospitals need to battle COVID-19 come from overseas, which makes the FDA’s Office of Regulatory Affairs (ORA) work imperative to ensure legitimate products are moving as quickly as possible through the ports of entry. At the same time, ORA imports staff also screens for, and blocks the entry of, unproven products that falsely claim to prevent, diagnose, treat or cure COVID-19.
  • Over the weekend, FDA issued an emergency use authorization (EUA) to Everlywell, Inc. for the Everlywell COVID-19 Test Home Collection Kit, the first standalone at-home sample collection kit that can be used with certain authorized tests. Everlywell’s kit is authorized to be used by individuals at home who have been screened using an online questionnaire that is reviewed by a health care provider. This allows an individual to self-collect a nasal sample at home using Everlywell’s authorized kit. The FDA has also authorized two COVID-19 diagnostic tests, performed at specific laboratories, for use with samples collected using the Everlywell COVID-19 Test Home Collection Kit.
  • Last week, the FDA approved another Abbreviated New Drug Application for Hydroxychloroquine Sulfate Tablets USP, 200 mg for the treatment of: (1) Uncomplicated malaria due to P. falciparum, P. malariae, P. ovale, and P. vivax. (2) Chronic discoid lupus erythematosus and systemic lupus erythematosus in adults and (3) Treatment of acute and chronic rheumatoid arthritis in adults. Side effects of hydroxychloroquine include irreversible retinal damage, cardiac effects (including cardiomyopathy and QT prolongation), worsening of psoriasis and porphyria, proximal myopathy and neuropathy, neuropsychiatric events, and hypoglycemia. The FDA recently posted information regarding shortages of hydroxychloroquine and chloroquine to its drug shortages webpage due to a significant surge in demand. The agency is working with manufacturers to assess their supplies and is actively evaluating market demand for patients dependent on hydroxychloroquine and chloroquine for treatment of malaria, lupus and rheumatoid arthritis.
  • Testing updates:
    • During the COVID-19 pandemic, the FDA has worked with more than 400 test developers who have already submitted or said they will be submitting EUA requests to the FDA for tests that detect the virus or antibodies to the virus.
    • To date, the FDA has authorized 103 tests under EUAs, which include 90 molecular tests, 12 antibody tests, and 1 antigen test.

Additional Resources:

Food and Drug Administration coronavirus update: May 9, 2020

May 9, 2020

The following is a press release from the U.S. Food and Drug Administration:

The U.S. Food and Drug Administration has issued the first emergency use authorization (EUA) for a COVID-19 antigen test, a new category of tests for use in the ongoing pandemic. These diagnostic tests quickly detect fragments of proteins found on or within the virus by testing samples collected from the nasal cavity using swabs. The EUA was issued late Friday to Quidel Corporation for the Sofia 2 SARS Antigen FIA. This test is authorized for use in high and moderate complexity laboratories certified by Clinical Laboratory Improvement Amendments (CLIA), as well as for point-of-care testing by facilities operating under a CLIA Certificate of Waiver.

Diagnostic testing is one of the pillars of our nation’s response to COVID-19 and the FDA continues to take actions to help make these critical products available, including by issuing EUAs. During this pandemic, there have been two types of tests for which the FDA has issued EUAs. One type are polymerase chain reaction (PCR) tests, a molecular diagnostic testing technique that detects the genetic material from the virus and can help diagnose an active COVID-19 infection. The other type are serological tests that look for antibodies to the virus, which can help identify individuals who have developed an adaptive immune response to the virus, as part of either an active infection or a prior infection (serological, or antibody, tests should not be used to diagnose active infection).

This latest FDA authorization is for an antigen test, which is a new type of diagnostic test designed for rapid detection of the virus that causes COVID-19. Each category of diagnostic test has its own unique role in the fight against this virus. PCR tests can be incredibly accurate, but running the tests and analyzing the results can take time. One of the main advantages of an antigen test is the speed of the test, which can provide results in minutes. However, antigen tests may not detect all active infections, as they do not work the same way as a PCR test. Antigen tests are very specific for the virus, but are not as sensitive as molecular PCR tests. This means that positive results from antigen tests are highly accurate, but there is a higher chance of false negatives, so negative results do not rule out infection. With this in mind, negative results from an antigen test may need to be confirmed with a PCR test prior to making treatment decisions or to prevent the possible spread of the virus due to a false negative.

Antigen tests are also important in the overall response against COVID-19 as they can generally be produced at a lower cost than PCR tests and once multiple manufacturers enter the market, can potentially scale to test millions of Americans per day due to their simpler design, helping our country better identify infection rates closer to real time.

This is just the first antigen test to be authorized and we expect more to follow. We also anticipate providing an EUA template for antigen tests, similar to ones we’ve released for other test types, to help manufacturers streamline submissions and help expedite our review and issuance of additional EUAs.

Antigen tests will play a critical role in the fight against COVID-19 and we will continue to offer support and expertise to help with the development of accurate tests, and to review and monitor marketed tests to ensure accuracy, while balancing the urgent need for these critical diagnostics.

For More Information:
FDA: FAQs on Diagnostic Testing for SARS-CoV-2 | FDA
CMS: Clinical Laboratory Improvement Amendments (CLIA)
CDC: Testing for COVID-19

Food and Drug Administration coronavirus update: May 1, 2020

May 1, 2020

The following is a press release from the U.S. Food and Drug Administration:

The U.S. Food and Drug Administration today continued to take action in the ongoing response effort to the COVID-19 pandemic:

  • Today, the FDA issued an Emergency Use Authorization (EUA) for the investigational antiviral drug remdesivir. The EUA allows for remdesivir to be distributed in the U.S. and administered by health care providers, as appropriate, to treat suspected or laboratory-confirmed COVID-19 in adults and children hospitalized with severe disease. Severe disease is defined as patients with low blood oxygen levels or needing oxygen therapy or more intensive breathing support such as a mechanical ventilator. Based on evaluation of the emergency use authorization criteria and the scientific evidence available, it was determined that it is reasonable to believe that remdesivir may be effective in treating COVID-19, and that, given there are no adequate, approved, or available alternative treatments, the known and potential benefits to treat this serious or life-threatening virus currently outweigh the known and potential risks of the drug’s use. For more information see: news releaseHealth Care Provider Fact Sheet and Patient Fact Sheet.
  • Today, the FDA updated its guidance on convalescent plasma and associated web page. The updated guidance provides clarification for investigators on how to submit investigational applications for COVID-19 convalescent plasma. In addition, the guidance includes updated information regarding potential donors. Previously, the FDA’s guidance noted that to qualify, individuals should have complete resolution of symptoms for 28 days or resolution for 14 and a negative diagnostic test. The revised guidance recommends that individuals  have complete resolution of symptoms for at least 14 days prior to donation A negative lab test for COVID-19 disease is not necessary to qualify for donation. The revised guidance also clarifies that FDA does not recommend storing a retention sample from the convalescent plasma donation for single patient emergency INDs.
  • To help address shortages of continuous renal replacement therapy (CRRT) products during the COVID-19 public health emergency, today the FDA issued an EUA to Fresenius Medical Care for emergency use of the multiFiltrate PRO System and multiBic/multiPlus Solutions. CRRT is a type of dialysis therapy used to filter and clean the blood when the kidneys are damaged or are not functioning normally. The Fresenius multiFiltrate PRO System and multiBic/multiPlus Solutions have been authorized to provide CRRT to treat patients in an acute care environment during the COVID-19 public health emergency.
  • Diagnostics update to date:
    • During the COVID-19 pandemic, the FDA has worked with more than 380 test developers who have said they will be submitting EUA requests to the FDA for tests that detect the virus.
    • To date, the FDA has issued 54 individual EUAs for test kit manufacturers and laboratories. In addition, 23 authorized tests have been added to the EUA letter of authorization for high complexity molecular-based laboratory developed tests (LDTs).
    • The FDA has been notified that more than 235 laboratories have begun testing under the policies set forth in our COVID-19 Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency Guidance.
    • The FDA also continues to keep its COVID-19 Diagnostics FAQ up to date.
  • The FDA included, under the ventilator emergency use authorization (EUA), a ventilator developed by the National Aeronautics and Space Administration (NASA), which is tailored to treat patients with COVID-19. The ventilator was added to the list of authorized ventilators, ventilator tubing connectors and ventilator accessories under the ventilator EUA that was issued in response to concerns relating to insufficient supply and availability of FDA-cleared ventilators for use in health care settings to treat patients during the COVID-19 pandemic. The NASA VITAL (Ventilator Intervention Technology Accessible Locally) is intended to last three to four months and is specifically tailored for patients with COVID-19, by providing respiratory support for patients that are experiencing respiratory failure or insufficiency. The device is designed to be built with components outside the current medical device supply chain and therefore does not impact the existing supply chain of currently made ventilators.
  • The FDA issued a Consumer Update, Helpful Questions and Answers about Coronavirus (COVID-19) and Your Pets, that provides answers to frequently asked questions. Based on the limited information available to date, the risk of pets spreading the virus that causes COVID-19 in people is considered to be low. At this time, there is no evidence that animals play a significant role in spreading the virus that causes COVID-19. There is a small number of animals around the world reported to be infected with the virus that causes COVID-19, mostly after having close contact with a person with COVID-19.
  • Today, the FDA issued a guidance highlighting flexibility under the Drug Supply Chain Security Act (DSCSA). This guidance is intended to facilitate the distribution of prescription drug products needed to respond to COVID-19, including drugs to treat symptoms of COVID-19. During the COVID-19 emergency, the DSCSA requirements related to certain product tracing and product identification activities, and wholesale distribution, do not apply to qualifying distribution activities. This flexibility balances the need for effective distribution of products under emergency conditions with protecting consumers from exposure to products that may be counterfeit, stolen or otherwise harmful.

Additional Resources:

Food and Drug Administration coronavirus update: April 20, 2020

April 20, 2020

The following is a press release from the U.S. Food and Drug Administration:

The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:

  • The FDA issued information on the use of serological (antibody) tests to help identify people who may have been exposed to the SARS-CoV-2 virus or have recovered from the COVID-19 infection. This information includes:
  • The FDA issued a face mask emergency use authorization (EUA) in response to concerns relating to insufficient supply and availability of face masks for use by members of the general public, including health care personnel in healthcare settings as personal protective equipment (PPE), to cover their noses and mouths, in accordance with Centers for Disease Control and Prevention (CDC) recommendations, to prevent the spread of the SARS-CoV-2 virus during the pandemic. Manufacturers of face masks that are used as described in the EUA and meet the requirements in the EUA, do not need to take any action, other than complying with the Conditions of Authorization in the EUA, to be authorized under this EUA.

  • Today, the FDA issued a guidance explaining a temporary policy regarding state-licensed pharmacies and federal facilities, that are not outsourcing facilities, compounding certain human drugs for hospitalized patients during the COVID-19 public health emergency. This guidance explains the agency’s policy to help address reported issues with accessing certain FDA-approved drugs used for hospitalized patients with COVID-19. As a temporary measure, with regard to certain drugs, under the circumstances outlined in the guidance, FDA does not intend to take action against state-licensed pharmacies and federal facilities for compounding a drug that is essentially a copy of a commercially available drug, or for providing a drug to a hospital without obtaining a patient-specific prescription. When a hospital is unable to access FDA-approved drug products and is considering the use of compounded drugs for hospitalized patients, outsourcing facilities may be able to offer a supply of compounded drugs that are subject to more robust quality standards than are drugs produced by State-licensed pharmacies or Federal facilities that are not required to comply with CGMP requirements.

  • A new FDA Voices was issued, The Path Forward: Coronavirus Treatment Acceleration Programdescribing a new program that aims to move new treatments to patients as soon as possible, while at the same time finding out whether they are helpful or harmful. So far, 72 clinical trials of potential therapies for COVID-19 are underway with FDA oversight. Both the pharmaceutical industry and academic researchers have submitted many innovative and well-designed studies for prevention and treatment of COVID-19. The FDA has streamlined its review and advice process to get studies started as quickly as possible.

  • Diagnostics update to date:
    • During the COVID-19 pandemic, the FDA has worked with more than 340 test developers who have said they will be submitting emergency use authorization (EUA) requests to FDA for tests that detect the virus.
    • To date, the FDA has issued 41 individual emergency use authorizations for test kit manufacturers and laboratories. In addition, 16 authorized tests have been added to the EUA letter of authorization for high complexity molecular-based laboratory developed tests (LDTs).
    • The FDA has been notified that more than 210 laboratories have begun testing under the policies set forth in our COVID-19 Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency Guidance.
    • The FDA also continues to keep its COVID-19 Diagnostics FAQ up to date.

Additional Resources:

Food and Drug Administration coronavirus update: April 10, 2020

April 10, 2020

The following is a press release from the U.S. Food and Drug Administration:

 

The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:

  • The FDA recently issued an emergency use authorization (EUA) for a blood purification system to treat patients 18 years of age or older with confirmed COVID-19 admitted to the intensive care unit with confirmed or imminent respiratory failure. The FDA issued the EUA to Terumo BCT Inc. and Marker Therapeutics AG for their Spectra Optia Apheresis System and Depuro D2000 Adsorption Cartridge devices.
  • The FDA recently issued an EUA to decontaminate compatible N95 or N95-equivalent respirators for reuse by health care workers in hospital settings. The FDA issued the EUA to STERIS Corporation for the STERIS V-PRO 1 Plus, maX and maX2 Low Temperature Sterilization Systems using the STERIS N95 Decontamination Cycle (non-lumen cycle), which uses vaporized hydrogen peroxide. This EUA will support decontamination of approximately 750,000 N95 respirators per day in the U.S.
  • The FDA issued a guidance for immediate implementation for pharmacy compounders that experience shortages of the personal protective equipment (PPE) they typically use to compound human drugs that are intended or expected to be sterile. PPE shortages have the potential to significantly impact the quality, purity and availability of drugs that are compounded for patients, including those in critical need. The guidance discusses how pharmacies may be able to preserve PPE if supplies are limited. Further, as a temporary measure to address the public health emergency posed by COVID-19, the agency is providing limited regulatory flexibility for compounders that cannot obtain sufficient supplies of PPE for sterile compounding, provided they adopt risk mitigation strategies as described in the guidance. FDA adopted this policy to help assure patient access to needed medicines and to reduce the risks of compounding when standard PPE are not available.
  • Yesterday, the FDA and Federal Trade Commission issued a warning letter to one company for selling fraudulent COVID-19 products, as part of the agency’s effort to protect consumers. The seller warned, Earthley Wellness DBA Modern Alternative Mama LLC., offers unapproved and misbranded herbal tinctures and herbal remedy products for the prevention or treatment of COVID-19. There are currently no approved preventatives or treatments for COVID-19. Consumers should not purchase or take any product to prevent or treat COVID-19 unless it is prescribed by their health care provider and acquired from a legitimate source.
  • FDA Voices: A Perspective on the FDA’s COVID-19 Response by Mitch Zeller, director of the FDA’s Center for Tobacco Products, was issued. It provides a perspective of the FDA’s “all-hands-on-deck” approach to tackling this pandemic. The FDA is integral in the fight against the coronavirus, using science and innovative approaches to take a broad range of actions that advance our nation’s response.
  • The FDA issued a Letter to Stakeholders advising people not use ivermectin intended for animals as a treatment for COVID-19 in humans. People should never take animal drugs, as the FDA has only evaluated their safety and effectiveness in the particular animal species for which they are labeled. These animal drugs can cause serious harm in people. People should not take any form of ivermectin unless it has been prescribed to them by a licensed health care provider and is obtained through a legitimate source.
  • Diagnostics update to date:
    • During the COVID-19 pandemic, the FDA has worked with more than 300 test developers who have said they will be submitting emergency use authorizations (EUA) requests to FDA for tests that detect the virus.
    • To date, 33 emergency use authorizations have been issued for diagnostic tests.
    • The FDA has been notified that more than 170 laboratories have begun testing under the policies set forth in our COVID-19 Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency Guidance.
    • The FDA also continues to keep its COVID-19 Diagnostics FAQ up to date.

Additional Resources:

Consumer Inquiries: 888-INFO-FDA

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

One World: Together at Home worldwide TV event honoring coronavirus health workers will include appearances by Elton John, Paul McCartney, John Legend, Lady Gaga, Chris Martin, Lizzo and more

April 6, 2020

Updated April 14, 2020

Lady Gaga (Photo by Erik Voake/Coachella)

The following is a press release from ABC:

Building on the success of the digital series “One World: Together at Home,” Global Citizen and the World Health Organization (WHO) are partnering for a special one-night event of the same name to air across NBC, ABC, CBS and other global networks and platforms on  Saturday, April 18, 2020 (8:00-10:00 p.m. PT/ET).

“One World: Together at Home” is not a telethon – but rather a global broad entertainment special to celebrate the heroic efforts of community health workers and support the World Health Organization and the global fight to end COVID-19. The event is curated by Lady Gaga and will feature exclusive appearances by Alanis Morissette, Andrea Bocelli, Billie Eilish, Billie Joe Armstrong of Green Day, Burna Boy, Chris Martin, David Beckham, Eddie Vedder, Elton John, FINNEAS, Idris and Sabrina Elba, Alanis Morissette, Andrea Bocelli, Billie Eilish, Billie Joe Armstrong, J Balvin, John Legend, Kacey Musgraves, Keith Urban, Kerry Washington, Lang Lang, Lizzo, Maluma, Paul McCartney, Priyanka Chopra Jonas, Shah Rukh Khan and Stevie Wonder. Friends of Sesame Street will also be on hand to help unify and inspire people around the world.

The two-hour program will be hosted by a trio of network late-night hosts: Jimmy Fallon, Jimmy Kimmel and Stephen Colbert and will include performances from the world’s biggest artists with multimillion-dollar pledges to the WHO’s Solidarity Response Fund. Audrey Morrissey (“The Voice,” “Songland”) and Live Animals will produce the special in partnership with Global Citizen.

The show will lift viewer’s spirits with exclusive, special cameos from the worlds of music and arts, sports superstars, and comedic sketches, while always drawing back to its core purpose – to educate and inform on COVID-19 risks, prevention and response. The broadcast will feature interviews with experts from WHO as well as stories of frontline healthcare workers from around the world – their courage and sacrifice a reminder of the urgency of this moment.

The special will connect artists with audiences on a global scale, airing on the following networks and platforms:

· NBCUniversal: NBC, Bravo, E!, MSNBC, MSNBC.com, NBCSN, NBC News, NBCNews.com, NBC News on YouTube, Peacock, SYFY and USA.

· Walt Disney Television: ABC, ABC News, ABC News Live, Freeform and Nat Geo.

· ViacomCBS: CBS, Channel 5 in the UK, Network 10 in Australia, and Telefe in Argentina; BET and MTV globally across 180+ countries; and CMT, Comedy Central, Logo, MTV2, Paramount Network, Pop, TV Land and VH1 in the U.S.

· Bell Media platforms in Canada, MultiChoice, and RTE.

· BBC One will broadcast an edited version of the event for UK audiences on Sunday, April 19.

“One World: Together At Home” will also be a multi-hour digital broadcast streaming online on multiple global platforms, including Alibaba, Amazon Prime Video, Apple, Facebook, Hulu, Instagram, LiveXLive, Tencent, Tencent Music Entertainment Group, TIDAL, TuneIn, Twitch, Twitter, Yahoo and YouTube. This digital special will include additional artists and performances from all over the globe as well as unique stories from the world’s healthcare heroes. For information about how to tune in and take action, visit www.globalcitizen.org/togetherathome.

Commitments from supporters and corporate partners will go to the COVID-19 Solidarity Response Fund, powered by the UN Foundation, to support and equip healthcare workers around the world, and to local charities that provide food, shelter, and healthcare to those that need it most. These local groups have been vetted to ensure they are helping communities impacted by COVID-19.

April 14, 2020 UPDATE: International advocacy organization Global Citizen today announced an expanded list of artists that will appear in the “One World: Together at Home” global broadcast special, being held in support of the global response to the COVID-19 pandemic being led by the World Health Organization.

The newly announced artists include Alicia Keys, Amy Poehler, Awkwafina, Camila Cabello, Celine Dion, Ellen DeGeneres, Jennifer Lopez, LL COOL J, Lupita Nyong’o, Matthew McConaughey, Oprah Winfrey, Pharrell Williams, Sam Smith, Shawn Mendes, Taylor Swift, Usher and Victoria Beckham. Curated in collaboration with Lady Gaga, the artists announced today join a lineup of entertainers who were unveiled last week that includes Andrea Bocelli, Billie Eilish, Billie Joe Armstrong of Green Day, Burna Boy, Chris Martin, David Beckham, Eddie Vedder, Elton John, FINNEAS, Idris and Sabrina Elba, J Balvin, John Legend, Kacey Musgraves, Keith Urban, Kerry Washington, Lang Lang, Lizzo, Maluma, Paul McCartney, Priyanka Chopra Jonas, Shah Rukh Khan and Stevie Wonder.

“One World: Together at Home” will be hosted by Jimmy Fallon of “The Tonight Show Starring Jimmy Fallon,” Jimmy Kimmel of “Jimmy Kimmel Live!” and Stephen Colbert of “The Late Show with Stephen Colbert.” Friends from Sesame Street will also be on hand to help unify and inspire people around the world to take meaningful actions that increase support for the global COVID-19 response.

Leading up to the global broadcast special, there will be a six-hour streamed event, curated from around the world, to support brave healthcare workers doing life-saving work on the front lines. The “One World: Together at Home” streamed event will reach millions around the world digitally and will include performances and appearances from Adam Lambert, Andra Day, Angèle, Anitta, Annie Lennox, Becky G, Ben Platt, Billy Ray Cyrus, Black Coffee, Bridget Moynahan, Burna Boy, Cassper Nyovest, Charlie Puth, Christine and the Queens, Common, Connie Britton, Danai Gurira, Delta Goodrem, Don Cheadle, Eason Chan, Ellie Goulding, Erin Richards, FINNEAS, Heidi Klum, Hozier, Hussain Al Jasmi, Jack Black, Jacky Cheung, Jack Johnson, Jameela Jamil, James McAvoy, Jason Segel, Jennifer Hudson, Jess Glynne, Jessie J, Jessie Reyez, John Legend, Juanes, Kesha, Lady Antebellum, Lang Lang, Leslie Odom Jr., Lewis Hamilton, Liam Payne, Lili Reinhart, Lilly Singh, Lindsey Vonn, Lisa Mishra, Lola Lennox, Luis Fonsi, Maren Morris, Matt Bomer, Megan Rapinoe, Michael Bublé, Milky Chance, Naomi Osaka, Natti Natasha, Niall Horan, Nomzamo Mbatha, P.K. Subban, Picture This, Rita Ora, Samuel L. Jackson, Sarah Jessica Parker, Sebastián Yatra, Sheryl Crow, Sho Madjozi, SOFI TUKKER, SuperM, The Killers, Tim Gunn, Vishal Mishra and Zucchero. The digital stream will be available on Alibaba, Amazon Prime Video, Apple, Facebook, Instagram, LiveXLive, Tencent, Tencent Music Entertainment Group, TIDAL, TuneIn, Twitch, Twitter, Yahoo and YouTube.

As part of the “One World: Together at Home” campaign, brands including Analog Devices, Cisco, Citi, The Coca-Cola Company, GlaxoSmithKline, IBM, Johnson & Johnson, PepsiCo, Procter & Gamble, State Farm(R), Target, Teneo, Verizon, Vodafone and WW International, Inc. have supported the COVID-19 Solidarity Response Fund for WHO and regional charities that are working to meet immediate COVID-19-related needs locally.

“We are grateful to the private sector who have listened to the public’s call for action and come together to support the global response to COVID19. This pandemic is too large for governments to tackle alone,” said Hugh Evans, co-founder and CEO of Global Citizen. “We are also incredibly grateful for the continued support from the artist community to make ‘One World: Together at Home’ a moment of global unity. Our hope for the special is that everyone will come away believing that we, as a shared humanity, can emerge from this moment forever grateful for the work of doctors, nurses, teachers, grocery store workers and all those who are the backbone of our communities.”

“One World: Together at Home” will air on Saturday, April 18, 2020, at 5:00 p.m. PDT/8:00 p.m. EDT, appearing on ABC, NBC, ViacomCBS Networks, The CW, iHeartMedia and Bell Media networks and platforms in Canada. Internationally, BBC One will run the program on Sunday, April 19, 2020. Additional international broadcasters include AXS TV, beIN Media Group, MultiChoice Group and RTE. The digital stream will begin at 11:00 a.m. PDT/2:00 p.m. EDT and will inspire unity among all people who are affected by COVID-19.

At this critical moment in history, Global Citizen is also calling on individuals, governments and philanthropists to join and support immediate COVID-19 response efforts. Changemakers, investors and foundation leaders are being urged to actualize their giving and invest quickly in related efforts, like stronger health systems and vaccine development.

Last month in response to the global pandemic, Global Citizen launched an urgent campaign in support of the COVID-19 Solidarity Response Fund for WHO. Calling on individuals to take action and asking world leaders and corporations to support the response with sufficient resources, Global Citizens from over 150 countries around the world have taken hundreds of thousands of actions in support of the response fund. For information about how to tune in and take action, visit globalcitizen.org/togetherathome.

For more information about Global Citizen and their campaign to support the WHO’s Solidarity Response Fund, please visit globalcitizen.org and follow @GlblCtzn Twitter, Facebook and Instagram using #GlobalCitizen.

To learn more about WHO’s response to the pandemic and the COVID-19 Solidarity Response Fund, please go to www.who.int/COVID-19 and follow @WHO on Twitter, Facebook, Instagram, LinkedIn and TikTok.

American Nurses Foundation launches coronavirus response fund for nurses

April 1, 2020

The following is a press release from the American Nurses Foundation:

Today, the American Nurses Foundation (the Foundation), the philanthropic arm of the American Nurses Association (ANA), announces the launch of the Coronavirus Response Fund for NursesJohnson & Johnson and the Tylenol brand made a $1.5M commitment to the launch of this fund.  Through this initiative, members of the public can demonstrate their appreciation and support for nurses who are on the frontline caring for patients during this pandemic, despite significant risk to their well-being and safety.

Through this national Coronavirus Response Fund, the public can thank and support nurses by texting THANKS to 20222 to make a $10 donation, which will:

  • Provide direct assistance to nurses serving on the frontlines and across other health care settings.
  • Support the mental health and well-being of nurses given the unprecedented stress of the situation.
  • Ensure all nurses have access to the latest scientific evidence to protect themselves, prevent the spread of the infection, and provide patient care.
  • Drive national advocacy to strengthen public health efforts and deploy critical medical supplies.

“Nurses always answer the call to serve their patients, communities and country during times of crisis. As we confront the new and emerging challenges of this pandemic, nurses are and will continue serving on the frontlines in extraordinary ways. This fund provides a way for members of the public to show appreciation and support for nurses’ commitment and sacrifice,” said the Foundation Chair Tim Porter-O’Grady, DM, EdD, ScD (h), APRN, FAAN, FACCWS. “We encourage like-minded individuals to contribute to this fund as a way to show our appreciation and support for nurses.”

A portion of the donations will help support Nurses House, Inc., a national fund for registered nurses in need. The Foundation is partnering with this organization to help nurses affected by COVID-19. Nurses who are unable to work due to COVID-19 infection, caring for a family member with COVID-19, or are under mandatory quarantine, can submit an application for assistance.

Nurses are reliable and proven responders during infectious disease emergencies, providing safe, quality, compassionate and nondiscriminatory care to their patients and the communities in which they serve. This Coronavirus Response Fund will enable the Foundation to readily assist all nurses who urgently need sufficient support and resources to effectively respond to this global health crisis.

About the American Nurses Foundation
The American Nurses Foundation is the charitable and philanthropic arm of the American Nurses Association (ANA), with the mission to transform the nation’s health through the power of nursing. The Foundation supports research, education, and scholarships, which improve health, wellness, and patient care. For more information visit www.nursingworld.org/foundation

About the American Nurses Association
The American Nurses Association (ANA) is the premier organization representing the interests of the nation’s 4 million registered nurses. ANA advances the nursing profession by fostering high standards of nursing practice, promoting a safe and ethical work environment, bolstering the health and wellness of nurses, and advocating on health care issues that affect nurses and the public. ANA is at the forefront of improving the quality of health care for all. For more information, visit www.nursingworld.org.