Researchers to test gene therapy for rare diseases with a new FDA trial protocol

Earlier this year, researchers at Children's Hospital of Philadelphia and Penn created a first-of-its-kind drug customized to a unique genetic mutation to save an infant named Baby KJ from dying of a ...
Becker's Hospital Review

Gap in FDA’s approval of AI radiology devices: 5 things to know

Study reveals a gap FDA approval AI radiology devices with only 29% undergoing clinical testing before clearance.
JD Supra

FDA Moves to Streamline Biosimilar Development: Implications for Regulatory Strategy and Clinical Study Design

The Food and Drug Administration (FDA) has issued new draft guidance signaling a policy shift toward reducing the need for comparative efficacy ...
STAT

Makary, Prasad outline pathway for bespoke gene therapy

FDA Commissioner Marty Makary and biologics chief Vinay Prasad have sketched out the agency’s first real blueprint for ...