FDA is hosting a meeting June 29 and 30 on “FDA Review and Regulation of Articles for the Treatment of Rare Diseases.” The hearing is intended to provide stakeholders, including the pharmaceutical industry, with an opportunity to present their views on the way FDA regulates the scientific evaluation of, marketing authorization for, and postmarket surveillance of, articles pertaining to drugs, biological products, and devices used for rare diseases. Written comments on this topic also will be accepted.