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Biotech / Medical : VVUS: VIVUS INC. (NASDAQ) -- Ignore unavailable to you. Want to Upgrade?

To: blankmind who wrote (5067)	1/28/1998 8:21:00 AM
From: sailor	Read Replies (1) \| Respond to of 23519

The FDA has already approved the drug MUSE. They also approve each and every manufacturing facility. They will have a annual inspections of each and every plant. ISO 9000 approval of the plant(s) will be done semi-annually, and then switch to annual. FDA is looking for cleanliness, manufacturing quality etc. The ISO people will be looking at good manufacturing procedures and quality control. FDA is US , and ISO is GB & EC. Sailor

To: blankmind who wrote (5067)	1/28/1998 9:48:00 AM
From: Tunica Albuginea	Respond to of 23519

blankmind, I believe by now your question has been answered. Simply, all plants have to be FDA approved. They can also approve it conditionally to you make some minor corrections, ( which is what happened with vivus in their ?spring 97 inspection). TA

To: blankmind who wrote (5067)	1/29/1998 7:12:00 PM
From: MissLil	Respond to of 23519

As part of the initial approval process, the process for producing the drug must be approved and the company must prove that they can produce a drug within manufacturing tolerances, with no unacceptable byproducts, with acceptable sterility and chemical stability. Without this, NO APPROVAL. Additional plants also need to be approved. Some of the tests that need to be done require time. Basically, they need to wait a while to make sure no microorganisms are growing in the drug and that the product is stable. The company can produce as much drug as it wants to without the FDA approval. They just can't sell it (a minor detail re: earnings reports). Hope this clears things up for you. This information is based on what I saw during my 18 months working for the FDA. I was not responsible for chemistry, but was involved with a few drugs where chemistry issues came up. Since I have performed similar tests in the laboratory (HPLC, microbiological assays, etc.) I was able to understand many of the details. LB