FDA Ups Pressure On Stem Cell Therapy Makers To Follow Product Approval Rules

US FDA is frustrated that few stem cell therapy makers are seeking regulatory approval of their products during the current enforcement grace period. 

Embryonic stem cells , Cellular therapy , Regeneration , Disease treatment , 3d illustration - Illustration
Embryonic stem cells

The US FDA is intensifying the spotlight on stem cell clinics, warning them that the discretionary period to determine whether they need to submit treatments as new products requiring a BLA will end soon enough and stepped up scrutiny will soon follow.

As part of its larger regenerative medicine policy framework, FDA is exercising regulatory discretion to allow firms up to November...

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