Two new draft industry guidances by the US Food and Drug Administration (FDA) clarify regulations enacted in 2009 for expanded access to investigational new drugs and the fees charged for them. The agency released the draft documents, Expanded Access to Investigational Drugs for Treatment Use and Charging for Investigational Drugs Under an IND in response to questions posed by healthcare professionals. Meg Egan Auderset at Thomson Reuters explains.
 
http://jforcs.com/jcs/wp-content/uploads/2013/07/1-New-Draft-Guidances-Clarify-Provisions-for-Expanded-Access-to-investigational-Drugs.pdf