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Robbie:
Here is a copy of your e-mail:
Don,
1. FDA’s: Is tolerable.
2. Yours: Interesting and I can see where you are going, but while the concept of "contribute" makes sense for the skin cancer warning, it does not for eyes (and overexposure for eyes doesn’t work either). Even "sunburn" which you introduced into the language would be more causally a consequence of OVERexposure, thus "contributes to" makes little sense here as well. I would think that eye injuries and skin injuries should be separated to make the warning more scientifically correct.
3. Canada’s: Terrible
4. Australia’s: Abominable. I’m glad I turned in my passport. It is interesting to note that both 3 and 4 are the result of socialized medicine, and accordingly the governments responsibility. The draconian measures vary only in degree to which these countries have socialized their medical professions.
Is this coming up at May 22? Should I be there?
Thanks.
Regarding your question as to what will be presented by FDA to TEPRSSC on 5/22/02. I have been informed by Dr. Cyr that ONLY the "Warning Label" language and "Amendment 3 - Definition of a Manufacturer" will be presented. We NEVER get the "agenda" until the day of the meeting. Could we be "blindsided"? Yes, but Dr. Cyr has never given us any reason not to trust him.
If you can get away to go, and I hope you can because you are very effective in these meetings, you need to "request" time to comment by e-mailing Dr. Orhan H. Suleiman and request time (ohs@cdrh.fda.gov) or calling him (301-594-3332) by TODAY 5/10/02.
Don
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