Wednesday, May 30, 2012

Surprise FDA Inspection May 29, 2012

FDA Site Visit

May 29th, 2012, the FDA made a surprise visit to one of our Multi-Center Registry sites. They asked to see all of our documentation and will be returning again May 30th, 2012. They provided no information on the reason for the visit or why that site was chosen first but did say that they would be doing inspections “all over the country”. The FDA did not shut down the site and as we have posted before we have already applied to the FDA for an exemption. Although the FDA’s primary intent is to prevent “advertising non approved uses for stents and balloons” it is unclear, so far, whether they also will stop research on CCSVI.

The Hubbard Foundation intends to continue to collect data on adverse events and changes in symptoms related to venoplasty (and ,hopefully, soon in relation to dietary and supplement interventions). An analysis of our first 259 patients has been accepted for publication and our multicenter Registry has collected data on over 400 people so far. We can’t see why the FDA would not want this data to be collected but we’ll keep you posted.

1 comment:

  1. Which site was "visited"? So in the eyes of the FDA, if you die due to complications caused by breast augmentation surgery, it's just one of those things - However, venoplasty used to treat a legitimate disease in the face of legitimate evidence supporting it, is a no go? Hmm... thanks big brother.