FDA Announces Proposed Changes to Clarify Orphan Drug Regulations

The Food and Drug Administration (FDA) recently published a Federal Register notice announcing proposed amendments to the agency’s 1992 orphan drug regulations. The proposed changes, which address a variety of issues related to orphan drug designation and exclusive approval, are intended to clarify existing regulatory provisions. Interested pharmaceutical companies and other stakeholders have until January 17, 2012, to submit comments on the proposed changes.

Click the link below to read the full alert.