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 issue opens with an in-depth analysis of the array of significant new developments that have occurred in 2017 in FDA’s push to strengthen its regulatory process for drug/device combination products. The focus than shifts to the experience and learnings of the first two companies to cross the CM approval finish line – Vertex and J&J’s Janssen. Moving to developments abroad, the final story centers around the impact on global excipient and pharma filings and product compliance of new requirements in China for the “bundling” of the excipient approval process with drug dossiers.