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Post# of 257442
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Biowatch

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Biowatch

Re: AlpineBV_Miller post# 28800

Wednesday, 05/17/2006 10:36:15 AM

Wednesday, May 17, 2006 10:36:15 AM

Post# of 257442
How are Class I and Class 2 defined?

How does the FDA define a Class 1 and Class 2 letter? What does it mean to get one versus the other?

Most companies who get an approvable letter usually say they need further discussions with the FDA to find out what they need to do, but the NBIX webcast was exceptionally brief on this issue.
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