RE: Docket No. FDA–2015–D–2818 Draft Guidance for Industry: Rare Diseases—Common Issues in Drug Development
The Biotechnology Industry Organization (BIO) appreciates the opportunity to provide feedback in response to the Food and Drug Administration’s (FDA’s) Draft Guidance for Industry, entitled “Rare Diseases: Common Issues in Drug Development” (Draft Guidance).
BIO is the world's largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial, and environmental biotechnology products.