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INTERNATIONAL PHARMACEUTICAL QUALITY
Inside the Global Regulatory Dialogue
IPQ Monthly Update – August / September 2016 in Review
In focus are: ● the concerns biotech product regulators in the U.S. and Europe are raising during their CMC and inspection reviews and the ongoing efforts to facilitate the development and clearance process ● the excipient/material issues that are surfacing in reviewing new drug delivery systems and how FDA’s inactive ingredient database (IID) can help, and ● how the vision of mutual inspection reliance between the U.S. and Europe is taking shape.
