Advocating for Rare Cancer Patients at the FDA through a Federal Citizen Petition

The Citizen Petition is a request that the FDA issue a formal "Guidance Document" outlining the process by which a drug company could gain approval for their products for a rare cancer use.  In November, 2005 the FDA asked for, and received, input from their own Federal Advisory Committee for suggestions on making approval easier and faster for rare cancers.  Our petition merely asks for a codification on what would be satisfactory clinical data to gain FDA approval.

• See the Citizen Petition to the FDA

• See a letter of support for the CP by Congressman Cooper

• See a letter of support for the CP by Congressman Kennedy

• See a letter of support for the CP by Congressman Ryan

• See a letter of support for the CP by Congressman Towns

• See a letter of support for the CP by Congressman Israel

• See a letter of support for the CP by Congressman Velazquez