Ann Begley

Wiley Rein LLP

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Latest Posts › Federal Food Drug and Cosmetic Act (FFDCA)

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Time’s Up! Cosmetic Facilities Must Comply With FDA’s New Registration Requirements by July 1

The July 1, 2024 deadline is fast approaching for cosmetic product manufacturers to comply with new registration and listing requirements under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). Passage of the...more

6/18/2024 / Cosmetics , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Health and Safety , Manufacturers , Modernization of Cosmetics Regulation Act of 2022 (MoCRA) , Personal Care Products , Product Labels

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FDA’s Remote Regulatory Assessments Q&A Draft Guidance Document Explains the Regulated Industry’s New Virtual Reality

The U.S. Food and Drug Administration (FDA or Agency) recently announced the availability of a new draft guidance titled “Conducting Remote Regulatory Assessments: Questions and Answers” (RRA Draft Guidance).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8/31/2022 / Coronavirus/COVID-19 , Draft Guidance , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , FSVP , Inspections , Virtual Meetings , Virtual Reality

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