The program, known as the Coronavirus Treatment Acceleration Program (CTAP), is using every tool at the agency’s disposal to bring new therapies to sick patients as quickly as possible, while at the same time supporting research to further evaluate whether these medical countermeasures are safe and effective for treating patients infected with this novel virus.FDA actions on hydroxychloroquine sulfate and chloroquine phosphate products, N95 respirators, surgical apparel for health care professionals, and more in its ongoing response to the COVID-19 pandemic.On April 1, 2020, the FDA will host the first of a series of virtual Town Halls for clinical laboratories and commercial manufacturers that are developing or have developed diagnostic tests for SARS-CoV-2.The FDA has been providing unprecedented flexibility to labs and manufacturers to develop and offer COVID-19 tests across the U.S. Every action the FDA has taken during this public health emergency to address the COVID-19 pandemic has balanced the urgent need to make diagnostic tests available with providing a level of oversight that ensures accurate tests are being deployed.The law grants the FDA transformative, new authorities that will meaningfully advance our efforts to modernize the OTC drug development and review process to help advance innovative, safe and effective options for consumers and secure a robust OTC marketplace.The FDA is continuously examining the global supply chain to identify any concerns and assess the availability of the products Americans need most. These are called convalescent plasma and hyperimmune globulin and are antibody-rich blood products made from blood donated by people who have recovered from the virus.FDA actions on blood donor eligibility, authorizing the first serology test to date, informing the public on food safety and the food supply, and more in its ongoing response to the COVID-19 pandemicAlmost 400 FDA Commissioned Corps officers have been deployed to aid in response to the coronavirus public health emergency.The FDA issued guidance for immediate implementation to address the urgent and immediate need for blood and blood components.FDA actions on the FDA-ARGOS SARS-CoV-2 Reference Grade Sequence Data, temporary flexibility to chain restaurants and similar retail food establishments, warning letters, and more in its ongoing response to the COVID-19 pandemicFood availability and food safety are vitally important to our well-being, and the FDA is working hard to help ensure the foods you, your family, and your pets eat are safe and available during the COVID-19 pandemic.FDA actions on the Coronavirus Treatment Acceleration Program, shortages of hydroxychloroquine and chloroquine, warning letters, and more in its ongoing response to the COVID-19 pandemic.The FDA stood up a new program to expedite the development of potentially safe and effective life-saving treatments. The purpose of this Town Hall is to help answer technical questions about the development and validation of tests for SARS-CoV-2.FDA actions on warning letters, false positive test results, and more in its ongoing response to the COVID-19 pandemic.FDA Commissioner Stephen M. Hahn, M.D., returns to FDA Insight to discuss food safety issues during the COVID-19 pandemic.FDA actions on diagnostic tests, including authorizations, and more in its ongoing response to the COVID-19 pandemic.The FDA issued an EUA for a COVID-19 antigen diagnostic test, the BD (Becton Dickinson) Veritor System for Rapid Detection of SARS-CoV-2.The FDA has issued an EUA for another combination diagnostic that can test for flu and COVID-19 to prepare for this upcoming flu season.FDA actions on methanol-contaminated hand sanitizers, the FDA COVID-19 Response At-A-Glance Summary, and more in its ongoing response to the COVID-19 pandemic.FDA is warning consumers and health care professionals about hand sanitizer products containing methanol, or wood alcohol that is dangerous and not an acceptable active ingredient for hand sanitizer products.FDA actions on issuance of testing-related emergency use authorizations, warning letters, diagnostic reference panel materials, and more in its ongoing response to the COVID-19 pandemic.FDA actions on vaccine development and licensure guidance, emergency use authorizations, diagnostics, and more in its ongoing response to the COVID-19 pandemic.The FDA published a guidance document to facilitate the timely development of safe and effective vaccines to prevent COVID-19, giving recommendations for those developing COVID-19 vaccines for the ultimate purpose of licensure. The FDA and FTC are taking this action as part of their response in protecting Americans during the global COVID-19 outbreak.The FDA hosted a town hall for laboratories certified to perform high-complexity testing under the Clinical Laboratory Improvement Amendments (CLIA) that are developing or have developed molecular diagnostic tests for SARS-CoV-2.The Commissioner's remarks highlighted the role of diagnostic testing in the COVID-19 response.The FDA hosted a webinar for laboratories certified to perform high-complexity testing under the Clinical Laboratory Improvement Amendments (CLIA), and others interested in learning more about this guidance.In a joint effort, the U.S. Food and Drug Administration and the Centers for Disease Control and Prevention took action to make more respirators, including certain N95s, available to health care personnel. Magazine and resource offering calendar of events, firm listings, jobs section, forums, articles and competitions. An official website of the United States government: Symptoms and signs include vomiting, watery diarrhea, or both.

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