US Pandemic Emergency Manufacturing Act Submitted Again By Warren, Schakowsky
Pandemic Emergency Manufacturing Act authorizes federal government and its contractors to make personal protective equipment, Rx drugs, ventilators, respirators and vaccines as well tests for coronavirus, including OTC products, to address the public health emergency.
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Biden administration seems to be betting Elluve's OTC at-home antigen diagnostic test will be a game changer in helping stop the spread of the coronavirus.
Sample-collection kit and testing firms acknowledge regulatory approval for OTC sales can be as complicated as the technology behind their products. But consumers have OTC access to numerous at-home collection kits for tests for indications of diseases or medical conditions as well as for genealogy. Kits approved for testing for influenzas or other infections also should become available OTC, say industry stakeholders.