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US Food and Drug Administration’s New Digital Health Innovation Action Plan Details a Software Precertification Pilot Program

In recognition that the traditional regulatory approach toward moderate to high risk medical devices is not well-suited for current digital health software products, the US Food and Drug Administration published a Digital...more

FDA Finalizes Rule Governing Establishment Registration and Listing for Human Drugs

On August 31, 2016, the US Food and Drug Administration published “Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License...more

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