In an effort to increase the number of drugs available to treat rare diseases and to help make the US Food and Drug Administration (FDA) more approachable, the FDA is hosting a series of workshops to encourage regulatory submissions for orphan drug designation for drugs aimed at treating rare diseases. The agency's Office of Orphan Products Development (OOPD) is holding these events to help academics, biotech companies and those unfamiliar with the process complete the best application possible. The first workshop, held in February at the Claremont, California–based Keck Graduate Institute, resulted in 14 submissions from the 29 potential sponsors who attended. Timothy Coté, director of the OOPD, explains that the workshops are “a way to demystify the process,” which is sometimes deemed to be daunting. “Sponsors approach the FDA with considerable fear and loathing. And that's not a good thing,” he says. Though an orphan drug status does not ensure a drug will be approved for sale, the designation typically helps attract investor interest and provides other benefits, such as seven years of market exclusivity and tax credits. Coté hopes that these workshops will be the “beginning of a more candid relationship” between the FDA and potential sponsors and that they will increase the chances of rare-disease therapies reaching the clinic.