March 12, 2013

Advancing “Breakthrough” Drug Therapies by #FDA's Dr. Janet Woodcock, MD

One in a series related to Provectus, PV-10 and the FDA's Breakthrough Therapy designation.

Dr. Woodcock's full blog post is here.

"The Food and Drug Administration Safety and Innovation Act, or FDASIA for short. It defines a “breakthrough” therapy as one that is “is intended, alone or in combination with one or more other drugs, to treat a serious or life-threatening disease or condition and for which preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.” In other words, a breakthrough drug is one that may offer important new benefits for patients with serious or life-threatening disease who are especially in need of new safe and effective treatments."

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