|FDA says they will consider new-fill for those who have started treatment
Dec 10, 2001
I received a call from the FDA on this issue, and the representative said that they would offer new-fill on a compassionate use basis to those who have already started treatment. They will require the following: 1) A narrative from the physician stating why new-fill is better for the patient than any other approved treatment (such as collagen) 2) IRB approval from a reviewer hired by the physician. Apparently this is easier to do than it sounds. 3) Informed consent from the patient. 4) Concurrence by a physician independent of the providing physician.
These will be reviewed on a case by case basis. I do not know the location to fax the info, but I will E-mail it to you as soon as I receive it.
The contact person at FDA is Mr. Paul Williams, at 301-594-1190, extension 110. He has been very helpful in this effort. Thank you for your efforts in this task as well.
Response from Dr. Fisher
I will post this for others to see. Thank you. AF
Why's of NewFill FDA BAN
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