Fed Regist. 2013 Jun 12;78(113):35117-35.
The Food and Drug Administration (FDA) is issuing final regulations amending the 1992 Orphan Drug Regulations issued to implement the Orphan Drug Act. These amendments are intended to clarify regulatory provisions and make minor improvements to address issues that have arisen since those regulations were issued.
美国食品药品监督管理局（FDA）正在发布最终法规，修订为实施《孤儿药法案》而颁布的1992年孤儿药法规。这些修订旨在澄清监管规定，并做出细微改进，以解决自这些法规发布以来出现的问题。
