Rejected – Accelerated New Therapy Consideration For Terminally Ill Patients!

A few weeks ago, Representative Towns (D-NY) introduced an amendment, "ACCELERATED NEW THERAPY CONSIDERATION FOR TERMINALLY ILL PATIENTS" to the PDUFA (Prescription Drug User Fee Act). The amendment would have required drug and biologic companies that develop new treatments for people with life threatening or terminal illness to also develop an expanded access program under [...]

Still Missing, The Prostate Cancer Community

Here it is June 11 and my frustration with the Prostate Cancer Community continues to climb. On May 31, I wrote that the FDA had compromised over the issue of the approval of Provenge. At that time, it was announced that the FDA would be willing to use the interim results of Dendreon’s current, on [...]

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