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Antibiotic Development: Limited Population Pathway In US Removes Barrier

 
• By Michael Cipriano

Allergan's Avycaz could be indicator of how FDA will use the 21st Century Cure's new approval mechanism; experts maintain the provision does not lower FDA's standards of safety.

Antibiotic resistant bacteria closeup biofilm

By codifying the removal of regulatory barriers, the limited population pathway provision for certain antimicrobial drugs in the 21st Century Cures Act will incentivize the development of infectious disease drugs that would impact small, specific populations, experts say.

There are several reasons why drugmakers have avoided antimicrobial development – antibiotic development in particular – over the past few decades. One such regulatory barrier has been the lack of available patients for clinical trials because of the small amounts of people the infections have impacted

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