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Hogan Lovells

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

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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

Hogan Lovells

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

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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

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