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Last up-date: April 13, 2010
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| Diabetic Gastroparesis |
GPDA's web site has been
recognized by WEGO Health
as an outstanding resource
for health information on
diabetic gastroparesis.
Thank you WEGO Health
for the award recognition!
GPDA’s action on domperidone for US citizens
In the summer of 2004 the US Food and Drug Administration issued an import ban on domperidone, placing in jeopardy ready access to a medication which improves quality of life for many gastroparetic sufferers.
GPDA responded with a formal letter to the FDA.
In September 2004, GPDA and a panel of experts organized by GPDA, met with the FDA New Drug Division and representatives from the FDA Compliance Office. This action was taken to try and remove the import ban issued by the FDA regarding domperidone.
In addition, our expert team consisting of toxicologists, a pharmacologist, two top motility experts and lawyers also presented to the FDA the seriousness of gastroparesis and the dire need for our patient population to have access to safe and effective medications.
Follow-up correspondence occurred with the FDA compliance office.
GPDA further provided a critique of the FDA's action on the withdrawal of Cisapride from the market withdrawal as well as the import alert on domperidone. This document was sent on to the FDA Ombudsman in the spring of 2005.
We are grateful for the very positive leadership and vision of the FDA. The FDA developed a special IND program in order for Americans suffering from gastroparesis to still have access to their medication.
