Zdrowie i gospodarka · 25/11/2025

FDA Proposes Changes to Nucleic Acid-Based Test Systems for Oncology Therapeutic Products

The FDA is proposing to reclassify certain nucleic acid-based test systems for use with approved oncology therapeutic products, shifting them from premarket approval to special controls, and introducing new device classification regulations to ensure safety and effectiveness.

Source: Federal Register — Food and Drug AdministrationOpen original release →

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Zdrowie i gospodarka · 10/5/2026

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