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December 01, 2010 (Vol. 30, No. 21)

Road to Antibiotic Approval Made Clearer

Regulatory Hurdles Are Higher, but a New Well-Defined Path Means We Know How High to Jump

  • Antibiotic development has become a challenging therapeutic area. Shifting and evolving regulatory guidelines have made design of clinical trials difficult and the prospect for marketing approval fairly low. In addition, the short-term treatment regimens have made the sector relatively unattractive from a return on investment perspective, particularly for antibiotics ...

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