Accelerating Product Development and Regulatory Approval for Drugs and Biologics in the US

The Food and Drug Administration (FDA) has created five mechanisms to presumably speed the approval of drugs and biologics that effectively treat serious diseases, especially those that are the first of their kind or those that provide increased benefit over existing treatments. 

Rho has provided what you really need to know about FDA’s Accelerated Approval, Breakthrough Therapy, Regenerative Medicine Advanced Therapy, Fast Track, and Priority Review programs.
 
 

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