ALSETF Submission to FDA In Response To [Docket No. FDA-2013-N-0035], Hearing on ALS Drug Regulation
Considerations Regarding Food and Drug Administration Review and Regulation of Drugs for the Treatment of Amyotrophic Lateral Sclerosis; Public Hearing
Presentation on Expanded Access
First presented Aug 1st, 2012 for pharma conference in Chicago, IL.
FDA Final Rule on EAP (2009)
FDA’s most recent edition of the code on expanded access programs.
FDA Charging Rule (2009)
Expanded access rules allow patients to cover the variable costs associated with their participation in expanded access programs. This is an enabling factor in many treatment programs. Details in 21 CFR 312.
A science paper for non-scientists learning about ALS. Neuroinflammation and cytokinetic cross talk.