FDA tweaks orphan drug rules

06/13/2013 | Regulatory Focus

The FDA has finalized changes to rules implementing the Orphan Drug Act. Under the new rules, "orphan subset" means a drug is appropriate for use in a subset of the population but not in the broader population. The agency also clarified that a drug may qualify for incentives even if it could be used to treat multiple patient populations, as long as each one is less than 200,000 patients.

View Full Article in:

Regulatory Focus

Published in Briefs:

SmartBrief Job Listings for Health Care

Job Title Company Location
Director of Actuarial Services, Government Programs
PacificSource
Springfield, OR
Director, Health Plan Claims Operations
Group Health Cooperative
Seattle, WA
Senior Director, Research
America's Health Insurance Plans (AHIP)
Washington, DC
Stop Loss Sales Executive
Blue Cross Blue Shield of MA
Boston, MA
Regional Director, Southeastern Region - State Affairs
America's Health Insurance Plans (AHIP)
Washington, DC