2 Jun 2014 - Last week the FDA finalised a guidance document regarding the use of its four expedited drug approval programmes, including the most recent addition to this roster – breakthrough product designation.

Intended for first-in-class drugs that treat serious conditions, breakthrough product designation was introduced in 2012 and can be granted to candidates based on preliminary clinical evidence indicating that that the drug may demonstrate substantial improvements on clinically significant endpoints versus available therapies.

The breakthrough designation represents a new approach from the FDA. Rather than expedite development based on a reduced regulatory timeline, this pathway is designed to provide developers access to an enhanced review process and "intensive guidance" regarding development of the product.

For more details, go to: http://www.firstwordpharma.com/node/1214352#axzz33bFrYfOO