The RAPS store will be under maintenance Saturday, 17 April between 5 AM and 12 PM EST. Store functionality may be unavailable at times during this window.
We apologize for any inconvenience caused during this time.

Regulatory Focus™ > News Articles > RAPS News: FDA/EMEA Common Application for Orphan Medicinal Products

RAPS News: FDA/EMEA Common Application for Orphan Medicinal Products

Posted 01 February 2008

On 8 November 2007, the US Food and Drug Administration (FDA) and European Medicines Agency (EMEA) announced a Common Application for Orphan Medicinal Product Designation. The intent of the common application is to reduce the administrative burden on companies who wish to apply to orphan medicinal product designation in both the US and EU and thus, hopefully, to increase the number of products available to treat rare or "orphan" diseases in both jurisdictions.

 

© 2021 Regulatory Affairs Professionals Society.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe