Drug Industry Daily

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The FDA’s lack of a policy or guidance to help API manufacturers deal with a new European directive is causing concern among manufacturers about lost sales and drug shortages in Europe, an expert says.

Bioniche and Endo Pharmaceuticals are halting their Phase III trial of non-muscle-invasive bladder cancer treatment Urocidin because the trial failed to recruit subjects at the expected rate.

A House Committee on Energy & Commerce subcommittee will question FDA Commissioner Margaret Hamburg at a Nov. 14 hearing on the recent fungal meningitis outbreak.

Ventrus is planning on a late-2013 NDA for VEN-307, a cream to treat anal fissure pain, after completion of a second Phase III trial.

The FDA has handed a cardiac surgeon at Washington, D.C.-based Washington Hospital Center a warning letter for not having institutional review board (IRB) approval when recruiting some patients into a clinical trial.