Ann Begley

Wiley Rein LLP

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Latest Posts › Coronavirus/COVID-19

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The End of an Era: FDA Announces Disposition Plans for COVID-19 Related Guidance Documents

The COVID-19 pandemic presented the U.S. Food and Drug Administration (FDA or Agency) with a monumental task of shifting its operations and the way it approached the regulation of critical drugs, medical devices, and biologic...more

3/17/2023 / CDRH , Center for Biologics Evaluation and Research (CBER) , Center for Drug Evaluation and Research (CDER) , Clinical Trials , Coronavirus/COVID-19 , Food and Drug Administration (FDA) , Medical Devices , Personal Protective Equipment , Public Health Emergency

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

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

11/8/2022 / CDRH , Coronavirus/COVID-19 , Department of Health and Human Services (HHS) , Emergency Use Authorization (EUA) , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Manufacturers , Medical Devices , Premarket Approval Applications , Public Health Emergency

FDA’s Remote Regulatory Assessments Q&A Draft Guidance Document Explains the Regulated Industry’s New Virtual Reality

The U.S. Food and Drug Administration (FDA or Agency) recently announced the availability of a new draft guidance titled “Conducting Remote Regulatory Assessments: Questions and Answers” (RRA Draft Guidance). Remote...more

8/31/2022 / Coronavirus/COVID-19 , Draft Guidance , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , FSVP , Inspections , Virtual Meetings , Virtual Reality

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