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FDA Roundup: October 11, 2022

For Immediate Release:

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:

•    Today, the FDA announced the launch of an independent study by the National Academies of Sciences, Engineering, and Medicine (NASEM) on the Role of Seafood Consumption in Child Growth and Development. The FDA is partnering with the National Oceanic and Atmospheric Administration, U.S. Department of Agriculture, and U.S. Environmental Protection Agency on this study, which supports the goals of the FDA’s Closer to Zero Action Plan for reducing the exposure of babies and young children to mercury, arsenic, lead and cadmium from foods. It will also help inform whether updates are needed for the current Advice about Eating Fish for children and those who might become, or are, pregnant or breastfeeding.

•    Today, the FDA’s Center for Devices and Radiological Health (CDRH) announced it is launching the voluntary Total Product Life Cycle Advisory Program (TAP) Pilot. The TAP Pilot is intended to demonstrate the feasibility and benefits of earlier and more frequent interactions with CDRH, strategic input from stakeholders, and proactive, strategic advice from CDRH to help spur more rapid development of high-quality, safe, effective and innovative medical devices of public health importance.

•    COVID-19 testing updates:
o    As of today, 436 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 299 molecular tests and sample collection devices, 85 antibody and other immune response tests, 51 antigen tests, and 1 diagnostic breath test. There are 79 molecular authorizations and 1 antibody authorization that can be used with home-collected samples. There is 1 EUA for a molecular prescription at-home test, 2 EUAs for antigen prescription at-home tests, 19 EUAs for antigen over-the-counter (OTC) at-home tests, and 3 for molecular OTC at-home tests.
o    The FDA has authorized 35 antigen tests and 8 molecular tests for serial screening programs. The FDA has also authorized 1127 revisions to EUA authorizations.
 

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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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