Quote:
Originally Posted by Fortunatos
Reynolds, This is really grasping at straws, but perhaps the FDA has a similar program. I can't see this flying with any physician here, however, I wonder if it would in the US?
"...Special Access Program (SAP) for Drugs and Medical Devices not Available in Canada: The Special Access Programme (SAP), via exemptions set out in C.08.010 and C.08.011 of the Food and Drugs Act and Part 2 Section 69-78 of the Medical Devices Regulations, allows physicians and dentists to gain access to health products for human use that have not been granted market authorization in Canada. Decisions to authorize this access are based on the circumstances and details of each situation. If authorization is granted, Health Canada provides a Letter of Authorization (LOA) to the manufacturer of the drug or device authorizing its sale to the requesting practitioner. A copy of this letter is sent to the practitioner. A copy of this letter must be sent with the shipment to allow timely entry of the drug/medical device into Canada..."
http://www.hc-sc.gc.ca/dhp-mps/compl...iu-uif-eng.php |
I have spoken to the FDA and they did tell me they will let it in. They are all for it. Santfi would not agree. The easiest way to get it is for the drug company to import it themselves. Santfi said it would cost too much money.
So now we are trying to set up a method to get it from France. I have heard nothing on that front. I have no idea if that will work or not. I suspect it is probably another dead end.