Two new rules clarify patients access to INDs
The U.S. Food and Drug Administration (FDA) published two final rules on Aug. 13, 2009, detailing how seriously ill patients might gain access to investigational new drugs.
Called "Expanded Access to Investigational Drugs for Treatment Use," and "Charging for Investigational Drugs Under an Investigational New Drug Application," the new rules provide detailed instructions for how such an expanded access initiative might work.
The expanded access rule establishes criteria that must be met to authorize the expanded access use, requirements for expanded access submissions, and safeguards to protect patients and preserve the ability to develop meaningful data.1
For more information, visit the FDA's Web site at www.fda.gov.
Reference
- Expanded access to investigational drugs for treatment use. Final rule. Fed Regis. 2009;74(155):40900-40945.
You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
- Award-winning Medical Content
- Latest Advances & Development in Medicine
- Unbiased Content