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APP Receives Expedited Approval for the First and Only Generic


APP Receives Expedited Approval for the First and Only Generic Cefotetan Disodium for Injection (Business Wire via Yahoo! Finance)
SCHAUMBURG, Ill.----Abraxis Pharmaceutical Products , the hospital-based business of Abraxis BioScience, Inc. , today announced the approval from the U.S. Food and Drug Administration to market Cefotetan Disodium for Injection, the generic equivalent of AstraZeneca's Cefotan .

SVS Independently Validates IDBS' E-WorkBook Suite Against 21 CFR Part 11 And GLP Requirements (PharmaceuticalOnline)
IDBS, a leading Electronic Laboratory Notebook (ELN) provider, recently announced that its complete E-WorkBook Suite has been independently validated by the Sociedad de Validaci n de Sistemas (SVS) against the FDA's 21 CFR Part 11 and Good Laboratory Practice (GLP) guidelines.

Industry will have to incur GMP costs (Nutraingredients.com)
8/10/2007 - While many in the supplement and nutraceutical industry have applauded the US Food & Drug Administration's (FDA's) issuance of the long-awaited final rule to establish GMPs, not every manufacturer will be able to bear the cost of compliance with the final rule.
 

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