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FDA Pharanaceutical Quality Oversight

FDA oversight of drug product quality has in the past been exercised through two key functions: 1) regulatory review of drug applications and 2) inspection of facility compliance with current good manufacturing practices (CGMPs). However, data available to the FDA show that pharmaceutical manufacturing and its regulation, in general, continue to manifest a number of problems:

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Tetraphase Pharmaceuticals

Tetraphase Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing novel antibiotics to treat the serious and life-threatening multidrug-resistant infections that pose a major and growing global health threat

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