SILVER SPRING, Md., March 30, 2020 /PRNewswire/ -- The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:

• On March 28, 2020, the FDA issued an Emergency Use Authorization (EUA) to allow hydroxychloroquine sulfate and chloroquine phosphate products donated to the Strategic National Stockpile (SNS) to be distributed and used for certain hospitalized patients with COVID-19. These drugs will be distributed from the SNS to states for doctors to prescribe to adolescent and adult patients hospitalized with COVID-19, as appropriate, when a clinical trial is not available or feasible. The EUA requires that fact sheets that provide important information about using chloroquine phosphate and hydroxychloroquine sulfate in treating COVID-19 be made available to health care providers and patients, including the known risks and drug interactions. The SNS, managed by ASPR, will work with the Federal Emergency Management Agency (FEMA) to ship donated doses to states.
  
  
  
  
• On March 29, 2020, the FDA issued an immediately in effect guidance that outlines an enforcement policy to help expand the availability and capability of sterilizers, disinfectant devices and air purifiers. The devices include those intended to make devices sterile, kill pathogens or other microorganisms and kill pathogens or microorganisms in the air. This policy reflects FDA's commitment to ease burdens on health care providers and facilities as they face COVID-19.
  
  
  
  
• The FDA amended the Emergency Use Authorization (EUA) for the Battelle Decontamination System for use in decontaminating compatible N95 respirators for reuse by health care personnel during the COVID-19 pandemic. This EUA is an important step forward in helping to reduce shortages in critical N95 respirators, by allowing for these important devices, when decontaminated, to be reused by medical professionals on the front lines of the COVID-19 pandemic.
  
  
  
  
• On March 30, 2020, the FDA issued an immediately in effect guidance to help expand the availability of surgical apparel for health care professionals, including gowns (togas), hoods, and surgeon's and patient examination gloves during this public health emergency.
  
  
  
  
• FDA and FTC issued warning letters to two companies for selling unapproved products claiming to mitigate, prevent, treat, diagnose or cure COVID-19. One of the companies, Corona-cure.com, was warned for selling the product Coronavirus Infection Prevention Nasal Spray with misleading claims on its website that its product is safe and/or effective for the treatment or prevention of COVID-19. The agencies also warned Carahealth for selling its herbal products, including "Carahealth Immune," with misleading claims of prevention and/or treatment of COVID-19. We are particularly concerned that unapproved drugs that claim to cure, treat, or prevent serious conditions may cause consumers to delay or stop appropriate medical treatment, leading to serious or life-threatening harm. There is currently no approved treatment or preventative measure for COVID-19. FDA and FTC are closely monitoring social media, the online marketplace, and incoming reports for fraudulent COVID-19 products on the market.
  
  
  
  
• The FDA issued an updated guidance, "Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic," with an appendix adding questions and answers on this subject. We plan to update this appendix as new questions arise. This guidance is intended for industry, investigators and institutional review boards and was issued because we recognize that the COVID-19 pandemic may impact the conduct of clinical trials of medical products, including drugs, devices and biological products.
  
  
  
  
• Diagnostics update to date: During the COVID-19 pandemic, the FDA has worked with more than 230 test developers who have said they will be submitting emergency use authorizations (EUA) requests to FDA for tests that detect the virus. To date, 20 emergency use authorizations have been issued for diagnostic tests, including Abbott Diagnostics Scarborough, Inc., ID NOW COVID-19, a rapid (13 minutes or less) test. Additionally, the FDA has been notified that more than 110 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:

• Coronavirus Disease 2019 (COVID-19)

Media Contact: Stephanie Caccomo, 301-348-1956

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.

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SOURCE U.S. Food and Drug Administration

SILVER SPRING, Md., March 27, 2020 /PRNewswire/ -- 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 is working closely with manufacturers to make sure that they continue to notify the agency of any permanent discontinuance or interruption of drug and biological product manufacturing in a timely manner. Today, the agency published guidance for immediate implementation about the importance of these notifications, the timelines for drug and biologic manufacturers to follow when notifying the FDA, and the details for manufacturers to provide about the discontinuance or interruption in manufacturing. Along with the requirements in the statute and implementing regulations, the guidance requests that applicants and manufacturers provide additional details and follow additional procedures to make sure the FDA has the specific information it needs to help prevent or mitigate shortages.
  
   
• The FDA issued a Consumer Update, Food Safety and Availability During the Coronavirus Pandemic, to describe the many ways the agency is working to help ensure the foods you, your family, and your pets eat are safe and available.
  
   
• The FDA issued a letter to stakeholders about the imminent threat to the health of consumers who may take chloroquine phosphate products used to treat disease in aquarium fish, thinking the products are interchangeable with FDA-approved drugs (used to treat malaria and certain other conditions in humans) that are being studied as a COVID-19 treatment for humans. Chloroquine products sold for aquarium use have not been evaluated by the FDA to determine whether they are safe, effective, properly manufactured, and adequately labeled for use in fish--let alone humans.
  
   
• Diagnostics update to date: During the COVID-19 pandemic, the FDA has worked with more than 220 test developers who have said they will be submitting emergency use authorizations (EUA) requests to FDA for tests that detect the virus. To date, 19 emergency use authorizations have been issued for diagnostic tests. Additionally, the FDA has been notified that more than 110 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:

• Coronavirus Disease 2019 (COVID-19)

Media Contact: Stephanie Caccomo, 301-348-1956

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.

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SOURCE U.S. Food and Drug Administration

SILVER SPRING, Md., March 26, 2020 /PRNewswire/ -- 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 guidance today on a Temporary Policy Regarding Nutrition Labeling of Certain Packaged Food During the COVID-19 Public Health Emergency. The FDA is issuing this guidance to provide restaurants and food manufacturers with flexibility regarding nutrition labeling so that they can sell certain packaged foods during the COVID-19 pandemic. For example, restaurants may have purchased ingredients that they can no longer use to prepare restaurant food and instead wish to sell to their customers.
• The FDA posted questions and answers related to consumer use of hand sanitizer during the COVID-19 public health emergency. The FDA wants to make consumers aware of the steps the agency is taking to increase the supply of hand sanitizer during this public health emergency. The questions also discuss hand washing, expiration dates and other frequently asked questions by consumers on hand sanitizer.
• Late yesterday, the FDA issued an immediately in effect guidance: Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease-2019 (COVID-19) Public Health Emergency. The FDA believes the policy set forth in this guidance may help address urgent public health concerns by helping to expand the availability of general use face masks for the general public and particulate filtering facepiece respirators (including N95 respirators) for health care professionals.
• The FDA took action today regarding 3D printing. The FDA entered into a Memorandum of Understanding (MOU) with the Department of Veterans Affairs and the National Institutes of Health, National Institute of Allergy and Infectious Diseases (NIH/NIAID), and is working with America Makes, the National Additive Manufacturing Innovation Institute, to facilitate connections between patients and healthcare providers, local manufacturers with capabilities, and designs for needed medical products. This MOU provides a framework for collaboration intended to facilitate regulatory and basic science innovation with 3D printing technologies to respond to COVID-19. Through this collaboration, the U.S. government and partners will help ensure that veterans and civilians have access to the most innovative medical solutions and technologies, including medical products that are manufactured close to the patient or at point-of-care. The FDA also issued FAQs on 3D Printing of Medical Devices During COVID-19 for entities who 3D print devices, accessories, components, and/or parts during the COVID-19 pandemic.
• Diagnostics update to date: During the COVID-19 pandemic, the FDA has worked with more than 220 test developers who have said they will be submitting emergency use authorizations (EUA) requests to FDA for tests that detect the virus. To date, 17 emergency use authorizations have been issued for diagnostic tests, including the AvellinoCoV2 test, which is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal and oropharyngeal swab specimens collected from individuals suspected of COVID-19 by their healthcare provider. Additionally, FDA has been notified that more than 100 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:

• Coronavirus Disease 2019 (COVID-19)

Media Contact: Stephanie Caccomo, 301-348-1956 

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.

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SOURCE U.S. Food and Drug Administration

SILVER SPRING, Md., March 25, 2020 /PRNewswire/ -- The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:

• In response to the demand for alcohol-based hand sanitizers and their active ingredient, alcohol, certain entities that are not currently regulated by the FDA as drug manufacturers have requested guidance on the preparation and distribution of alcohol for incorporation into hand sanitizer products for the public's use. The FDA issued another guidance for industry about hand sanitizers, Temporary Policy for Manufacture of Alcohol for Incorporation Into Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) Guidance for Industry. The guidance is for firms that manufacture alcohol (i.e., ethanol or ethyl alcohol) for use as the active pharmaceutical ingredient (API) in alcohol-based hand sanitizers for consumer use and for use as health care personnel hand rubs for the duration of the public health emergency.
  
   
• The FDA added hydroxychloroquine sulfate to category 1 under the Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act. The FDA does not intend to object to registered outsourcing facilities using hydroxychloroquine (or chloroquine phosphate, which was already on category 1), to compound human drugs provided the drugs meet other conditions and requirements in the FD&C Act. Compounding is generally a practice in which a licensed pharmacist, a licensed physician, or, in the case of an outsourcing facility, a person under the supervision of a licensed pharmacist, combines, mixes, or alters ingredients of a drug to create a medication tailored to the needs of an individual patient. The FDA is placing hydroxychloroquine sulfate on category 1 after it reviewed the nomination and determined there was sufficient information for the agency to evaluate the substance for outsourcing facilities to use in compounding. When FDA categorized hydroxychloroquine sulfate it did not change its approach, but we prioritized this substance due to the COVID-19 pandemic. There are currently no FDA approved therapeutics or drugs to treat, cure or prevent COVID-19; however, there are FDA-approved treatments that may help ease the symptoms of COVID-19. Additionally, state-licensed pharmacies and federal facilities that compound drugs under section 503A of the FD&C Act may compound drugs using hydroxychloroquine sulfate or chloroquine phosphate bulk drug substances because they are components of an FDA-approved drug, provide other requirements in the Act are met.
  
   
• The FDA issued an emergency use authorization for ventilators, anesthesia gas machines modified for use as ventilators, and positive pressure breathing devices modified for use as ventilators (collectively referred to as "ventilators"), ventilator tubing connectors, and ventilator accessories. Manufacturers and other stakeholders may submit a request to FDA under the process outlined in the EUA to have their device(s) added to the EUA. If you have questions, please email CDRH-NonDiagnosticEUA-Templates@fda.hhs.gov.
  
   
• Diagnostics update to date: During the COVID-19 pandemic, the FDA has worked with more than 190 test developers who have said they will be submitting applications to make tests that detect the virus. To date, 16 emergency use authorizations have been issued for nation-wide use. Additionally, under our COVID-19 laboratory developed test policy, the FDA has been notified by more than 100 laboratories. The FDA also added additional updates to its COVID-19 Diagnostics FAQ.

Additional Resources:

• Coronavirus Disease 2019 (COVID-19)

Media Contact: Stephanie Caccomo, 301-348-1956

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.

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SOURCE U.S. Food and Drug Administration

SILVER SPRING, Md., March 24, 2020 /PRNewswire/ -- 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 is facilitating access to convalescent plasma, antibody-rich blood products that are taken from blood donated by people who have recovered from the COVID-19 virus, that could shorten the length, or lessen the severity, of the illness. The agency will be using multiple pathways to support these efforts and has posted information for investigators wishing to study convalescent plasma for use in patients with serious or immediately life-threatening COVID-19 infections through the process of single patient emergency Investigational New Drug Applications for individual patients. The FDA also is actively engaging with researchers to discuss the possibility of collaboration on the development of a master protocol for the use of convalescent plasma, with the goal of reducing duplicative efforts.

• In response to this evolving public health emergency and continued filtering facepiece respirator (FFR or respirator) shortages, FDA has concluded based on the totality of scientific evidence available that certain imported disposable FFRs that are not NIOSH-approved are appropriate to protect the public health or safety. Under this EUA, authorized respirators listed in the letter 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 Coronavirus Disease 2019 (COVID-19) outbreak.
• Letter of Authorization
• Non-NIOSH Approved Respirator EUA FAQ

• The FDA issued a Consumer Update advising consumers to be beware of fraudulent coronavirus tests, vaccines and treatments. The FDA is particularly concerned that deceptive and misleading products might cause Americans to delay or stop appropriate medical treatment, leading to serious and life-threatening harm. It's likely that the products do not do what they claim, and the ingredients in them could cause adverse effects and could interact with, and potentially interfere with, essential medications. There are no FDA-approved products to prevent COVID-19. For example, the FDA is aware of people trying to prevent COVID-19 by taking a product called chloroquine phosphate, which is sold to treat parasites in aquarium fish. Products for veterinary use or for "research use only" may have adverse effects, including serious illness and death, when taken by people. The agency warns not to take any form of chloroquine unless it has been prescribed by a health care provider and obtained from legitimate sources.

• Diagnostics update: In certain emergencies, the FDA can often quickly issue an emergency use authorization for diagnostic tests based on FDA's rolling review of data and where the request meets certain criteria. In the COVID-19 pandemic, the FDA has worked with more than 190 test developers who have said they will be submitting applications to make tests that detect the virus. To date, 16 emergency use authorizations have been issued for nation-wide use, including one today. Under our laboratory developed test policy during COVID-19, the FDA has been notified by more than 65 laboratories.

• The FDA issued a Letter to Industry that includes steps the Center for Devices and Radiological Health (CDRH) has taken to prioritize work that advances the nation's response during the Coronavirus Disease 2019 (COVID-19) public health emergency. These steps seek to address the impact of COVID-19 public health emergency on day-to-day operations in CDRH and in the medical device industry, while ensuring that government and private sector efforts to respond to this national emergency receive the highest priority.

• The FDA provided flexibility to veterinarians who want to utilize telemedicine to prescribe certain drugs for animals by temporarily suspending enforcement of portions of the federal veterinarian-client-patient relationship requirements. This helps veterinarians continue to care for animals while minimizing person-to-person contact between veterinary staff and the animal owner or caretaker, allowing for the social distancing that is so important in limiting the further spread of coronavirus.

• The FDA explained how the agency is working with experts around the world to find ways to prevent and treat COVID-19, including collaborating with international organizations to facilitate the development of a vaccine: FDA Voices: FDA and EMA Collaborate to Facilitate SARS-CoV-2 Vaccine Development.

• The FDA took action to increase U.S. supplies to support the U.S. response to COVID-19 by providing instructions to manufacturers importing personal protective equipment and other devices. The agency is engaging with importers and others involved in the import trade community during this pandemic to facilitate the entry of needed products, including PPE, into the U.S. These instructions to importers clarify the types of PPE that can be imported without engaging with FDA. They also include information about the type of information importers can submit to facilitate their entries.

• The FDA provided an update, FDA Offers Assurance About Food Safety and Supply for People and Animals During COVID-19, to explain that the U.S. food supply remains safe for both people and animals. There is no evidence of human or animal food or food packaging being associated with transmission of the coronavirus that causes COVID-19. Additionally, overall, retail supply chains remain strong, and the FDA is working with food manufacturers and grocery stores to closely monitor the human food supply chain for any shortages. The same is true for animal food. The FDA is monitoring the availability of foods for livestock and pets. There are no shortages, and no current disruptions in the pet and livestock food supply chain.

Additional Resources:

• Coronavirus Disease 2019 (COVID-19)

Media Contact: Stephanie Caccomo, 301-348-1956

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.

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SOURCE U.S. Food and Drug Administration

SILVER SPRING, Md., March 23, 2020 /PRNewswire/ -- Today, the U.S. Food and Drug Administration took the following actions in our ongoing response effort to the COVID-19 pandemic:

• The FDA issued a safety alert for fecal microbiota transplantation (FMT) procedures. The FDA has issued a safety communication about the potential for transmission of the COVID-19 virus through FMT, a procedure that delivers human donor stool into the colon of a patient to treat c. difficile infection in patients that have not responded to standard therapies.
  
  
  
  
• The FDA also updated its recommendations regarding specimen collection for COVID-19 testing. Based on available data, FDA believes that, for symptomatic patients, nasal swabs could be used that access just the front of the nose rather than the depth of the nasal cavity. This would provide COVID-19 testing that is more comfortable for patients, allows self-collection of specimens at collection sites, and that can be performed with a simpler and more readily available swab.
  
  
  
  
• The FDA Oncology Center of Excellence issued a message recognizing that patients with cancer, due to potentially being immunocompromised, are at greater risk of contracting COVID-19, and the Center is working to address critical needs of patients with cancer and their health care providers.
  
  
  
  
• Diagnostics update: In certain emergencies, the FDA can often quickly issue an emergency use authorization for diagnostic tests based on FDA's rolling review of data and where the request meets certain criteria. In the COVID-19 pandemic, the FDA has worked with more than 160 test developers who have said they will be submitting applications to make tests that detect the virus. To date, 15 emergency use authorizations have been issued for nation-wide use, including two today. Under our laboratory developed test policy during COVID-19, the FDA has been notified by more than 65 laboratories.

"The FDA is doing everything we can to support patients, health care professionals, manufacturers of FDA-regulated products and the public during this pandemic," said FDA Commissioner Stephen Hahn, M.D. "The FDA is working around the clock to monitor and mitigate emerging coronavirus issues through collaborative efforts with federal partners, international regulators and medical product developers and manufacturers to help advance response efforts to combat the COVID-19 outbreak."

Additional Resources:

• Novel Coronavirus

Media Contact: Stephanie Caccomo, 301-348-1956

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.

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SOURCE U.S. Food and Drug Administration