renders incentives for sponsors to make items for rare diseases, that may comprise tax credits towards the expense of clinical trials and prescription drug user fee waivers.
1m grant from US FDA OOPD
in support of Phase 2 trial of its lead Lm Technology immunotherapy candidate, ADXS-HPV
Applications receive intensive review, first by OOPD
program staff for scientific and technical merit, and then by a panel of independent experts.
According to the company, the OOPD
is tasked with evaluating the scientific and clinical data submissions from sponsors to identify and designate products as promising for rare diseases and to further advance scientific development of such promising medical products.
The FDA, through OOPD, funds the development of orphan products through its grants program for clinical studies.
Gaining Orphan Drug Designation also makes the company eligible for the research funding provided by OOPD, in addition to receiving tax credits for certain research expenses and a waiver of the FDA application user fees.
The OOPD refused to consider one-year incidence of critical limb ischemia (CLI), and instead based their decision on a population beyond those patients with late-stage CLI.
We were surprised by the decision of the OOPD, which based its estimate on a five-year rate of incidence.
Correspondence from OOPD suggested clarification was required regarding the patient population to obtain approval for an application submitted by the Company in August 2001 for treatment of patients with Critical Limb Ischemia.
Orphan Drug is a designation from the OOPD, Food and Drug Administration (FDA) to indicate a therapy developed to treat a rare disease (one that afflicts a U.
Lamy has a wide depth of experience with FDA's, CDER, CBER, DEA, OOPD
and host of international health agencies.