The American Society of Hematology has notified me that the FDA's Dr. Richard Pazdur has issued a statement concerning "Expanded Access to Investigational Drugs for Treatment Use" and "Charging for Investigational Drugs." These are two significant new rules.
Links follow (for cut and paste use).
http://edocket.access.gpo.gov/2009/pdf/E9-19004.pdf and
http://edocket.access.gpo.gov/2009/pdf/E9-19005.pdf.
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