GeneQuine Biotherapeutics Granted Sponsor Fee Waiver by FDA [ 28 May 2015 ]

FDA grants GeneQuine Biotherapeutics a sponsor fee waiver under the significant barrier to innovation provision of ADUFA (Animal Drug User Fee Act) for FY 2015.

FDA’s decision is based on the assessment that GeneQuine Biotherapeutics is pursuing innovative drug products and technology in the development of gene therapy for treatment of osteoarthritis. This incentive supports GeneQuine’s development of innovative drugs and helps opening an INAD (Investigational New Animal Drug) file to discuss with the FDA the development and regulatory process for GeneQuine's drug candidates towards marketing authorization in the US.