FDA Support for Developing Products for Rare Diseases & Conditions

The FDA Office of Orphan Products Development (OOPD) mission is to advance the evaluation and development of products (drugs, biologics, devices, or medical foods) that demonstrate promise for the diagnosis and/or treatment of rare diseases or conditions.  In fulfilling that task, OOPD evaluates scientific and clinical data submissions from sponsors to identify and designate products as promising for rare diseases and to further advance scientific development of such promising medical products. The office also works on rare disease issues with the medical and research communities, professional organizations, academia, governmental agencies, industry, and rare disease patient groups.Continue reading

Webinar Series Shares the Basics of Biotech

The Basics of Biotech Webinar Series is specifically geared toward the non-science professional who needs to better understand industry terminology, science, techniques and issues.  This 3-part webinar series provides an overview of the science and technology used to enable discovery and the processes scientists use to discover new therapeutics.Continue reading