Following is the text of the FDA announcement:

Final Rules for Expanded Access to Investigational Drugs for Treatment Use and Charging for Investigational Drugs

FDA is amending its investigational new drug application (IND) regulation with two final rules:

	Expanded Access to Investigational Drugs for Treatment Use (PDF - 603KB)
	Charging for Investigational Drugs (PDF - 394KB)

The final rule, "Expanded Access to Investigational Drugs for Treatment Use," amends regulations on expanded access to investigational new drugs for treating patients. The final rule clarifies existing regulations and adds new types of expanded access for treatment use. Under the final rule, expanded access to investigational drugs for treatment use will be available to:

	individual patients, including in emergencies
	intermediate-size patient populations
	larger populations under a treatment protocol or treatment investigational new drug application (IND)

It is intended to improve access to investigational drugs for patients with serious or immediately life-threatening diseases or conditions who lack other therapeutic options and who may benefit from such therapies. The rule goes into effect 60 days from date of publication in the Federal Register.

Web site that explains the options for investigational drugs

	Consumer Information by Audience
	For Patients and Patient Advocates
	Access to Investigational Drugs Deciding Whether to Seek Access to an Investigational Drug Clinical Trials and Investigational Drugs Access to Investigational Drugs Outside of a Clinical Trial (Expanded Access)

8/14/09

Source
U.S. Food and Drug Administration (FDA). Final Rules for Expanded Access to Investigational Drugs for Treatment Use and Charging for Investigational Drugs. August 12, 2009.