NDA Delays: Blindsided By Site Problems

The Food & Drug Administration is listening to Capitol Hill about clinical trial data. The agency knows that both critics and defenders of the drug industry want it to ensure the credibility and integrity of clinical trial sites. Sponsors face another source of NDA delays.

By Cole Werble

Disappointed, perplexed and unable to comment on the future approval timelines for their pending antibiotic NDAs: that’s how the managements...

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