1. Pink Sheet

ICH Urged to Allow for Bioaccessibility in Metal Impurities Standards

 
• By Bowman Cox

The world’s leading drug regulatory authorities aim to agree in a June ICH meeting on final standards for elemental impurities like arsenic, lead, cadmium and mercury. Industry has some ideas on what they should decide.

KEY POINTS

As international limits on elemental impurities in pharmaceuticals near final approval, industry is arguing for relaxing the standards for certain...

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