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Strategies & Market Trends : Bosco & Crossy's stock picks,talk area -- Ignore unavailable to you. Want to Upgrade?

To: Steve Misic who wrote (3401)	5/28/2003 5:28:19 AM
From: Crossy	Read Replies (3) \| Respond to of 37387

Stephen, easy.. GCMP means Good Certified Manufacturing Practices or similarly .. it's bascially an FDA based quality standard that builds the basis for the FDA-approved manufacturing of substances inside a particular plant ANDA means Abbreviated New Drug Application. Ordinary (new) compounds require an NDA (new Drug application) - the entire "new compound pipeline" you might know from biotech investing. However for a generics formulation tis would be overkill. All required is essentially a proof of bioequivalence - a rather abbreviated study - which is done in an ANDA filing. If you want more insights into these matters, I would suggest to search some of the biotech related threas on SI or to go directly to the FDA website (should be www.fda.gov) to obtain more detailed info.. rgrds CROSSY