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A Step Forward: FDA Issues Three Draft Guidance Documents As Part of Efforts to Modernize the 510(k) Notification Pathway

On September 7, 2023, FDA issued three new draft guidance documents intended to strengthen the 510(k) premarket notification pathway for medical devices.

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FDA Issues Two Important Documents Concerning Communication of Off-Label Information

Practices: FDA Regulatory, Advertising & Promotion, Congressional Investigations & Public Policy, Due Diligence Reviews & Transactional Support, FDA Enforcement Actions & Litigation, Post-Approval Compliance, Regulatory Strategy, Product Development & Product Approvals

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