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IPQ Inside the global regulatory dialogue

FDASIA Heightens Focus on Proactive Communications with FDA; Timeliness, Accuracy and Transparency are Key, GMP Compliance Experts Advise

Jun 28th, 2014

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The provisions in the FDA Safety and Innovation Act (FDASIA) for communicating with FDA about manufacturing issues that could play out in drug shortages or facilitate regulatory surveillance are heightening industry’s focus on the agency’s...

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