ALS Association Drafting Drug Development Guidance; Learning From DMD Advocacy
This article was originally published in RPM Report
A Lou Gehrig’s disease patient advocacy group is moving forward with a drug development guidance of its own to the jumpstart the regulatory approval process.
You may also be interested in...
FDA has selected CFS/ME as the first topic for the PDUFA V patient-centered drug development initiative. The lessons learned from this session will inform future work on patient engagement in drug development both for FDA—and for patient advocates.
US FDA’s 22nd Patient-Focused Drug Development meeting focused on the challenging disease of autism. It also showed how far FDA has come in embracing the patient-input process over the past five years.
US agency's top neurology review officials received warm reception during Patient Focused Drug Development meeting for Spinal Muscular Atrophy. They also delivered a strong message of continued engagement beyond the first drug approval.