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Case Detail


In re Tier 1 Initial Approval Program
(Regulatory Proceeding)
WLF filed a citizen petition with the FDA on June 11, 2003, to seek faster drug availability for terminally ill patients. WLF is representing the Abigail Alliance for Better Access to Developmental Drugs, an Arlington, Va.-based group of terminally ill patients and parents of terminally ill patients who have tried and failed to obtain access to drugs that are tied up in the FDA's approval process. WLF's petition urges the adoption of a preliminary approval program, "Tier 1 Initial Approval," that would make promising new drugs available to patients with life-threatening illnesses while clinical trials and FDA reviews are underway. The petition shows in detail that such a program is within the FDA's statutory authority and does not require new legislation.
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