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McDermott Will & Emery

Healthcare Regulatory Check-Up Newsletter | May 2024 Recap

McDermott Will & Emery on

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for May 2024. We discuss several notable cases and enforcement resolutions, including the US Court of Appeals for the District of...more

Wilson Sonsini Goodrich & Rosati

Drug Use-Related Software Back in the Spotlight at the U.S. Food and Drug Administration

Wilson Sonsini Goodrich & Rosati on

In late September 2023, the U.S. Food and Drug Administration (FDA) released a draft guidance on “Regulatory Considerations for Prescription Drug Use-Related Software.” This guidance expands on (and was developed in response...more

Hogan Lovells

Another step forward in digital health: FDA issues draft guidance for drug master files (DMFs) for electronics and software...

Hogan Lovells on

On Monday, the FDA published the draft guidance, “Type V DMFs for CDER-Led Combination Products Using Device Constituent Parts With Electronics or Software,” which could facilitate drug manufacturers’ ability to integrate...more

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