Tuesday 13 May 2014

Unprecedented Collection of Duchenne Experts Developing Guidance for FDA - PPMD Community

Unprecedented Collection of Duchenne Experts Developing Guidance for FDA - PPMD Community: "The process for writing a Draft Guidance on Duchenne for the FDA and industry is in full swing.
As you know, the purpose of this guidance is to assist sponsors in the clinical development of medical products (i.e., human drugs and therapeutic biological products) for the treatment of Duchenne over the entire spectrum of the disease (ambulatory and non ambulatory). It is the result of the first collaboration between the FDA and a rare disease community to produce clinical guidance in their respective disease area."



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