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Premarket Approval Applications Emergency Use Authorization (EUA)

Wiley Rein LLP

Be Prepared: FDA Signals Transition Countdown for Medical Devices Marketed Under COVID-Era Enforcement Policies, EUAs

Wiley Rein LLP on

On October 17, 2022, the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) released the list of guidance documents proposed for publication in fiscal year 2023. While it is unclear if...more

Foley & Lardner LLP

COVID-19 Lab Tests: HHS Withdraws Policy Limiting FDA’s Review, and FDA Issues an Updated Policy Requiring EUAs

Foley & Lardner LLP on

On November 15, 2021, the U.S. Department of Health and Human Services (HHS) announced the withdrawal of the policy established during the previous administration that limited U.S. Food and Drug Administration’s (FDA) ability...more

Foley & Lardner LLP

USPTO Announces New Program To Promote Publication Of COVID-19 Innovation

Foley & Lardner LLP on

In an effort to both promote innovation against COVID-19 and promote dissemination of information about innovation against COVID-19, the USPTO is launching a new “deferred fee” pilot program for certain provisional patent...more

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