FDA Issues Final Revisions To Orphan Drug Act Regulations

The Food and Drug Administration issued final revisions to its orphan drug regulations to clarify provisions and make minor improvements to address issues that have arisen since the regulations were issued in 1992, according to a notice to be published June 12 in the Federal Register.

The Orphan Drug Act provides incentives for the development of potentially promising orphan drugs that otherwise would not be developed for rare diseases and conditions, the agency said. The proposed regulations were released in October 2011 (5 LSLR 1018, 10/21/11). The final regulations go into effect Aug. 12.

In a separate ...