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Biotech / Medical : CEPH -- Ignore unavailable to you. Want to Upgrade?

To: Russian Bear who wrote (738)5/13/1998 4:03:00 AM
From: SnowShredder  Read Replies (1) | Respond to of 998
 
RB,

I got this from the FDA web page:

As a condition of approval, however, FDA can require the sponsor to carry out post-marketing studies to confirm that the drug does in fact produce a clinical benefit, such as increased survival time. And if further research or experience shows that a product that received accelerated approval cannot safely remain on the market, FDA can order its prompt withdrawal.

But I have also heard this called a phase 4 trial...so maybe you are both right :) <eom>

Where'd He Go?



To: Russian Bear who wrote (738)5/13/1998 5:22:00 PM
From: Apple Jacks  Respond to of 998
 
There are such things as Phase IV trials. As you said, they are post marketing trials. I worked in drug development so I know something about it...


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