FDA Proposes Changes to Orphan Drug Regulations

This post was also written by Areta L. Kupchyk and Erin A. Janssen.

On October 19, 2011 the Food and Drug Administration (“FDA”) published a proposed rule in the Federal Register that would amend the 1992 Orphan Drug Regulations issued to implement the Orphan Drug Act (the “Proposed Rule”). Comments to the Proposed Rule should be submitted no later than January 17, 2012. This client alert summarizes these proposed changes and discusses the potential impact of the Proposed Rule on the drug, biological product, and biotechnology industry.

To read the full alert, click here.