USA – FDA Finalizes ALS Drug Development Guidance

The US Food and Drug Administration (FDA) on Monday finalized guidance to assist in the clinical development of treatments for amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s disease.

The 11-page guidance, which finalizes a draft version from February 2018, includes information on general development, safety and effectiveness considerations, as well as specific effectiveness trial considerations.

The guidance incorporates parts of a guidance put together by the ALS Association, known for its viral « ice bucket challenge. »

Changes made between the draft and final versions, according to FDA, also took into consideration written and verbal comments on the draft…