Yesterday, the FDA made a surprise visit to one of our sites. They asked to see all of our documentation and will be returning again today. 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.
Donnchadh wrote:Für die Arzneimittelentwicklung ("for drugs") (FDA) in hot pursuit of an IR allegedly performing forbidden venoplasty procedures.
To aid in controlling these banned procedures, authorities are issuing an order that all Multiple Sclerosis patients have a "MS" patch sewn on their clothing.
Users browsing this forum: No registered users