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Generics Bulletin

Medtech Insight

FDA Receives Thousands Of Opinions On Proposal To Regulate LDTs As Comment Period Comes To A Close

Dec 01 2023

• By Brian Bossetta

PROSvCONS — • Source: Shutterstock

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United States FDA Regulation Policy Gene Therapy Innovation Legislation Rare Diseases Regulatory Review Pathway Risk Management Safety Diagnostics Cancer Cardiovascular Blood & Coagulation Disorders Immune Disorders Infectious Diseases Oncology Respiratory Cardiology Blood Disorders In Vitro Diagnostics Patient Monitoring Quality Control Standards Medical Device

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