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Biotech / Medical : Zonagen (zona) - good buy? -- Ignore unavailable to you. Want to Upgrade?


To: Dauntless who wrote (2891)3/20/1998 10:50:00 PM
From: Dauntless  Respond to of 7041
 
New FDA web page

The CDER has apparently revamped its web page - click on the following link and poke around some. Good basic info for anyone interested in the drug approval process - great "interactive flow charts" & other explanations of the IND, NDA processes, etc., etc.,.....

fda.gov

Info "from the Horse's mouth"



To: Dauntless who wrote (2891)3/20/1998 10:55:00 PM
From: Hank  Read Replies (1) | Respond to of 7041
 
Hey, I'll give you the benefit of the doubt by admittng the possibility that I am wrong. However, I can tell you from personal experience that it is not unheard of for a small Biotech that is desperately in need of cash to embelish the efficacy data on a potential new drug in order to receive big drug money. You're assuming that SGP is infallable and that it is impossible for them to be fooled. There are con artists everywhere in this world and the pharmaceutical industry is no different. Even large drug firms are capable of making serious mistakes. Otherwise, every drug they submit to the FDA would be approved. In the instances where a big drug company submits an NDA and gets rejected by the FDA there is no doubt that the drug firm in question truly believes their drug is worthy of approval. It's called human error and bias. We all have it.