India, May 1 -- May has just begun, and it's time to turn our attention to the FDA decisions on deck for the coming weeks.
So far this year, the U.S. regulatory agency has approved only nine novel drugs - new molecular entities (NMEs) having chemical structures that have never been approved before. This number pales in comparison to 15 novel drugs approved during the same period last year (January through April).
Last month, Martin A. Makary, M.D., M.P.H., was appointed the 27th Commissioner of the FDA. Just days into his tenure, on April 10, he announced that the U.S. regulatory agency would begin reducing its reliance on traditional animal testing in the development of monoclonal antibody therapies and other pharmaceuticals. In its plac...