Amyloidosis group to submit guidance to FDA

The Amyloidosis Research Consortium (ARC) plans to submit a draft guidance to FDA by spring 2016 on the clinical development of products to treat amyloidosis, according to President and CEO Isabelle Lousada.

She said the not-for-profit advocacy group is modeling its guidance on draft guidance submitted to the agency in June 2014 by Parent Project Muscular Dystrophy (PPMD) and a coalition of stakeholders on the development of drugs for Duchenne muscular dystrophy (DMD). FDA issued its draft guidance for DMD in June 2015 (see BioCentury, June 15). ...