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International Organization for Standardization Proposed Rules

McDermott Will & Emery

FDA Issues Proposed Rule to Amend Medical Device Quality System Regulation

The US Food and Drug Administration (FDA) published its Medical Devices; Quality System Regulation Amendments proposed rule to amend the medical device Quality System Regulation (QSR) on February 23, 2022. While FDA generally...more

McDermott Will & Emery

FDA Proposes to Modify Good Laboratory Practice Regulations, Broaden Application and Authority

McDermott Will & Emery on

On August 24, 2016, the US Food and Drug Administration (FDA) issued a Proposed Rule on Good Laboratory Practice for Nonclinical Laboratory Studies (Proposed Rule), which broadens the application and authority of Good...more

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