Re: Radioactive Seeds

[Kerembaev@cs.com]

Craig,

I agree with you, that it would unethical to promote a new device before the 
FDA's approval and even more to promote safety of something in the direct 
way. 
I am not proposing to promote safety nor efficacy of new devices but the fact 
that phenomena saves the human and animals lives.
Believe me, that a promoting radioactivity in general will help you with the 
approval and all other cases related to the CAUSE.
Isn't the first amendment to the constitution protecting the right to say, 
also on the TV, the fact that the radioactivity and the ionized radiation as 
the phenomenas are saved and continue saving human and animals lives?
I haven't gone to law school yet and I do not think with my writing I ever 
will but..
X-ray fluoroscopy, Radiation therapy were saving lives since the times when 
the ionized radiation and radioactivity were discovered. So, we cannot really 
say that it is a new thing. I believe, Madam Maria Skaladovskay-Curie saved a 
lot of human lives during the World War I with a fluroscopical usage of the 
radioactivity before, hers all alone rudimental Ra-226 extortion technique, 
handling tons of the uranium ore when nobody around believed in her, catch up 
with her and finally killed her.
So, excuse me, but I have to disagree with the opinion that general 
info-mercial will not be consistent with the federal regulations. If you need 
an idea for the general info-mercial I have a plenty of time for them.

I have heard about your device among the regulatory community in 1995, so 
finally it looks like it going thru, I bet you had to go thru many usual as 
well as thru many very unusual problems.........
Good luck!
Respectfully,

Emil.
kerembaev@cs.com


In a message dated 2/7/00 5:40:55 Pacific Standard Time, CReed@novoste.com 
writes:
<< 
 To your question about an informercial: Intravascular Brachytherapy is
 not yet approved by the FDA for commericial use in the United States.
 Although Novoste Corporation has approval for the therapy OUTSIDE the US
 and Investigational Device Exemption(s) to conduct clinical trials
 inside  the US, we are awaiting clinical data from our trials in order
 to complete the FDA Pre-Market Approval Process.
 
 So, to your point, an info-mercial for the general US public promoting
 safety and efficacy of a technology would not be consistent with 21 CFR
 812.7.
 
 Craig Reed
 Radiation Regulatory Manager
 Novoste Corporation
 creed@novoste.com
  >>

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