Provided below are:
● the table of contents (p.1) ● information about IPQ (p.2), and ● the editor’s note on the issue (p.3)
FDA’s vision of a quality regulatory process that would be more efficient, science-based, review/inspection coherent, and process improvement and product supply friendly took more concrete shape during 2015. The January Monthly Update explores what the progress looks like across CDER’s Offices of Generic Drugs and Pharmaceutical Quality. Also in focus is the complex web of challenges that a global drug distribution system presents in trying to identify and trace products and what regulators and industry are trying to do to deal with it.