martes, 24 de septiembre de 2019

Statement on final guidance to help advance development of novel treatments for ALS | FDA

Statement on final guidance to help advance development of novel treatments for ALS | FDA





Statement on final guidance to help advance development of novel treatments for ALS

Over the past few years we’ve witnessed new medical breakthroughs that are altering how diseases are treated in ways that seemed unimaginable just a decade ago. We recognize that scientific progress across different disease and therapeutic areas has been uneven, particularly lagging for complex neurological diseases, such as amyotrophic lateral sclerosis (ALS). In part, this is because the underlying causes of severe neurological diseases are often not well understood, contributing to the challenge in the development of drug and biological treatments.

 Despite years of research and the availability of some approved therapies, we know the lack of new treatments for ALS is deeply frustrating for patients and caregivers. Staff from the FDA have been meeting regularly with members of the ALS community, including patients, their families and caregivers, and have heard their concerns loud and clear. We recognize the kind of strength it takes to ...

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