08/29/07 FDA Examines Orphan Drugs Availability to Patients

[admin]

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Orphan Drugs'' has been approved by the Office of Management and Budget (OMB). The information collection focuses on encouraging sponsors to make investigational orphan drugs available for treatment of persons in need on an open protocol basis before the drug has been approved for general marketing. Open protocols may permit patients who are not part of the formal clinical investigation to obtain treatment where adequate supplies exist and no alternative effective therapy is available.

For more information:
http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-17094.htm