Silver Spring, MD – The U.S. Food and Drug Administration (FDA) has announced the following actions taken in its ongoing response effort to the COVID-19 Coronavirus pandemic:
Given the anticipated increase in demand for chloroquine phosphate and hydroxychloroquine sulfate, the FDA is taking steps to ensure that adequate supply of these drug products is available for patients.
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Products Available
- The FDA published product-specific guidances [2] (PSGs) to support generic drug development for these drugs. The new PSG for chloroquine phosphate clarifies that the product is AA rated in the Approved Drug Products with Therapeutic Equivalence Evaluations publication (Orange Book), meaning that there are no known or suspected bioequivalence problems, and no in vivo studies are necessary. The revised PSG for hydroxychloroquine sulfate adds advice about a Biopharmaceutics Classification System-based biowaiver option.
- The FDA is currently prioritizing review of any newly submitted Abbreviated New Drug Applications (ANDAs) for chloroquine phosphate and hydroxychloroquine sulfate under MAPP 5240.3: Prioritization of the Review of Original ANDAs, Amendments, and Supplements [3].
The FDA issued a Consumer Update: How You Can Make a Difference During the Coronavirus Pandemic [4]. It explains ways to help, such as donating blood, protecting yourself and others, saving protective equipment for front line workers and reporting fraudulent products to the agency.
The FDA added new questions and answers to the webpage Q&A for Consumers: Hand Sanitizers and COVID-19 [5]. These new questions focus on unintentional ingestion of hand sanitizer by children, as there has been an increase in calls to Poison Control for unintentional ingestion of hand sanitizer during the COVID-19 pandemic.
The FDA issued an Emergency Use Authorization (EUA) [6] for the emergency use of the Perfusor Space Syringe Infusion Pump System, Infusomat Space Volumetric Infusion Pump System, and Outlook ES (“B. Braun Space and Outlook Pumps”) for use in the tracheal delivery of continuous nebulized medications into a nebulizer to treat patients of all ages with or suspected of having COVID-19 and decrease the exposure of healthcare providers to such patients during the COVID-19 Coronavirus pandemic. The EUA was also issued for ground medical transport use of the Infusomat Space Volumetric Infusion Pump System.
The FDA issued an Emergency Use Authorization (EUA) [7] to Advanced Sterilization Products, Inc. (ASP) for the ASP STERRAD Sterilization Systems that has the potential to decontaminate approximately 4 million compatible N95 or N95-equivalent respirators [8] per day in the U.S. for single-user reuse by health care workers in hospital settings. This authorization is intended to help increase the availability of respirators so health care workers on the front lines can be better protected and provide the best care to patients with COVID-19.
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Diagnostics update to date:
- During the COVID-19 Coronavirus 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, 34 emergency use authorizations [9] have been issued for diagnostic tests.
- The FDA has been notified that more than 180 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 [10] up to date.
Additional Resources:
Consumer Inquiries: 888.INFO.FDA
About the U.S. Food and Drug Administration
The U.S. Food and Drug Administration (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.