Regulatory Affairs Professionals Society

FDA drafts guidance on using next-generation sequencing to assess gene therapy safety

The US Food and Drug Administration (FDA) has released draft guidance on how sponsors can utilize next-generation sequencing ...

RNA sequencing platform unlocks rare disease diagnoses missed by standard tests

Researchers from Children's Hospital of Philadelphia (CHOP) developed a new RNA sequencing strategy that can reveal how genetic variants disrupt gene function and improve the diagnosis of rare ...
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How AI is helping scientists design the next generation of RNA medicines

Medical innovation is accelerating, yet the path from discovery to approved treatment remains slow and resource-intensive. For many patients, that delay matters. Researchers are now exploring whether ...
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Clinical Impact of Integrating RNA-Based Next-Generation Sequencing Into the Diagnostic Evaluation of Soft Tissue Sarcomas: Insights From a Single-Center Multidisciplinary Workflow

Radiation-Associated Sarcoma in a Resource-Constrained Setting: A Decade of Real-World Outcomes From a Tertiary Care Sarcoma Center in India This study illustrates a pragmatic model for implementing ...