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PATIENT PRIVACY IN AN ERA OF SOCIAL MEDIA
Early in the new year, the US Food and Drug Administration (FDA) released two anticipated draft guidance documents focused on artificial intelligence (AI): Artificial Intelligence-Enabled Device Software Functions: Lifecycle...more
The U.S. Food and Drug Administration (FDA) recently announced final guidance for firms in the medical device and product industry titled, “Communications From Firms to Health Care Providers Regarding Scientific Information...more
On September 19, 2023, the U.S. Food and Drug Administration (“FDA” or “the Agency”) published a draft guidance, Regulatory Considerations for Prescription Drug Use-Related Software (the “Guidance”) which adds a piece to the...more
On December 27, 2020, the President signed into law the “Consolidated Appropriations Act, 2021” (the “Act”). Included within this omnibus legislation are several provisions (in Division BB, Title III, Subtitle C) that affect...more
Legal, Regulatory and Commercial Perspectives on the International Biosimilars Marketplace - The Global Biosimilars market is expected to grow robustly. Market watchers anticipate that Europe in particular will experience...more