Provided below are:
● the table of contents (p.1) ● information about IPQ (p.2), and ● the editor’s note on the issue (p.3)
IPQ continues its in-depth exploration of the changes FDA is making to its quality regulatory structure, processes and expectations – their impact and global significance. Focal points include: ● a progress report on OPQ’s first year ● the manufacturing innovation taking place in the more nourishing regulatory environment ● other key issues on the current OPQ agenda ● CDER’s new risk-based API review process, and ● reviewer concerns with biotech product excipients. Also covered on the international front are EDQM’s efforts to drive API regulatory harmonization.