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Biotech / Medical : Agouron Pharmaceuticals (AGPH)
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To: Peter Singleton who wrote (4268)5/7/1998 3:45:00 PM
From: Tom DuBois  Read Replies (2) of 6136
 
Wonder if someone can help educate me on FDA trials. My understanding is that Phases I, II and III are carefully monitored, tightly controlled activities that yield verifiable scientific data relative to the safety, efficacy and dosing regimens for a particular drug. The culmination of these typically yrears-long efforts is an NDA submission to FDA.

If this is the case, why does the FDA take from 1-2 years to rule on the NDA? What goes on within the FDA that could possibly take this long? Certainly they must review the trials, check the methodologies and evaluate the data...but can this take so long? Is it a volume issue or government inefficiency?

Guess I don't understand, but it seems to me that once the rigorous trials are done, the FDA could verify the results and rule in shorter order. Even the vaunted "fast track" seems overly long to me. What am I missing?

Tom
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