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FDA finalizes RRA manufacturing inspection guidance as US focuses on supply chain security

The U.S. Food and Drug Administration (FDA) recently issued final guidance entitled “Conducting Remote Regulatory Assessments,” which explains the agency's plans to continue utilizing its records request authority and virtual...more

Why medical device companies must prioritize compliance with DOJ's Data Security Program

This regulation is designed to protect U.S. national security by restricting the transfer of bulk sensitive data to foreign entities associated with “countries of concern,” including China, Russia, Iran, North Korea, Cuba,...more

White House and OSTP release RFI concerning the development of an Artificial Intelligence Action Plan

On February 6, 2025, the Trump Administration released published a Request for Information (RFI) on behalf of the White House Office of Science and Technology Policy (OSTP) concerning the development of an Artificial...more

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