PPMD asks FDA to clarify DMD decisions

In a letter to FDA, the leader of not-for-profit advocacy group Parent Project Muscular Dystrophy urged the agency to explain more clearly its recent regulatory decisions and reviews of four therapies to treat Duchenne muscular dystrophy.

PPMD President and CEO Pat Furlong wrote that the agency has left the DMD community "greatly concerned about the consistency and transparency of the FDA approval process." The letter was addressed to Janet Woodcock, director of FDA's Center for Drug Evaluation and Research. ...