Provided below are:
● the table of contents (p.1) ● information about IPQ (p.2), and ● the editor’s note on the issue (p.3)
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.