martes, 9 de junio de 2015

Drug Information Update- FDA issues draft guidance on developing drugs for Duchenne Muscular Dystrophy

FDA Division of Drug Information: Know the Moment It Happens
The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.

FDA today issued a draft guidance for industry, “Duchenne Muscular Dystrophy and Related Dystrophinopathies: Developing Drugs for Treatment,” to assist drug companies in the clinical development of drugs for the treatment of X-linked Duchenne muscular dystrophy (DMD) and related diseases, including Becker muscular dystrophy, DMD-associated dilated cardiomyopathy, and symptomatic carrier states in females.
For the first time, the development of FDA guidance was preceded by the submission on June 25, 2014, of aproposed draft guidance independently prepared by an advocacy group, Parent Project Muscular Dystrophy (PPMD). FDA values PPMD’s effort and input and appreciates the insights provided by the DMD community. PPMD’s proposed draft guidance was posted on the web for public comment. Both the proposed guidance and public comments submitted to FDA were carefully considered in developing FDA’s draft guidance.
To learn more, please visit: DMD.

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