To ScottPosted by Pauline on 4/19/01 at 09:28 (045073)
I went back and looked at some of the earlier posts on the subject of te Orbasone Machine and it looks like this has been a controversial topic for some time.
I have a question:
I think of the FDA as a giant ATM machine, a manufacturer puts in an application and pays the fee--- and bingo when the drawer opens a
dated and stamped approval letter appears for their machine.
An individual can also put money in to retreave information, Other information is available free. I got the drawer to spit out a copy of the approval letter for Healtronics OssaTron, but I can't get it to spit out an approval anything for the Orbasone. Do you have a copy of the orginal FDA approval letter for the Orbasone?
In the OssaTron approval letter and attachments it spells out how the OssaTron has to be used which I think for a patient is a very important asset and security blanket. If you have a copy of the approval letter for the Orbasone what restrictions or requirements does the FDA attach to its approval letter? What does it say about how and where it is to be used, what conditions and who can use it?
Also I noticed in the (site location) area that there is no date listed when Dr. Biehler's machine was installed. Does he not know when? Have you encouraged him to post the results from the patients he has been treating. I remember Dr. Z brought him to the board when he (Dr.Z) was going on a trip surely some encouraging words from Dr.Z would get his data started on the site. I think results from more locations would be an asset to the findings.