Provided below are:
● the table of contents (p.1) ● information about IPQ (p.2), and ● the editor’s note on the issue (p.3)
The first two stories in this issue explore the drug GMP compliance concerns that are most pressing on the FDA agenda as 2018 approaches. The third story returns to the intensifying global dialogue on the stresses industry and regulators are feeling as they wrestle with how to advance drug/biologic/device combination products in the context of regulatory structures and processes not very well adapted to handle them.