Antimicrobial approvals are not bottlenecked by FDA

RAPS

3 June 2020 - Sponsors seeking US FDA approval for anti-microbial drugs accessed expedited clinical testing and review programs at least as frequently as those seeking approval of non-antimicrobials, according to a study published Tuesday in The Lancet Infectious Diseases. 

The median time from investigational new drug application to drug approval was shorter for antimicrobials than other drugs.

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Michael Wonder

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Michael Wonder

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Medicine , US , Regulation , Timelines