PPMD has been honored to lead the Duchenne community in developing patient-focused tools like our draft guidance and our benefit/risk surveys to help accelerate the FDA review of Duchenne treatments. Just last week, FDA issued its landmark draft guidance on Duchene therapy development, a document heavily informed by the project submitted nearly one year ago and led by…Continue
Added by Ryan Fischer on June 19, 2015 at 1:00pm — No Comments
Amazing things happen when this community works together, when our messages are consistent, and our goals are in sync. We work together, we change the landscape, we make history.
Today the FDA has released their draft guidance on Duchenne. This is the first…Continue
Last week we met with FDA to discuss status and potential release of guidance. As you know, we submitted draft guidance to FDA in June, 2014. FDA posted the guidance for public comment for a…Continue
Added by Pat Furlong on June 3, 2015 at 12:00pm — No Comments