This case study is based on the experience of one of the authors but is applicable to all companies across the broader industry, illustrating the potentially surprising point that some compliance difficulties may be of the company’s own making.
The FDA opened an expedited IND pilot, tightened scrutiny of foreign trial data, and finalized a rule recognizing non-animal testing methods. In Europe, the EMA advanced pharmaceutical legislation reform, restricted 2 legacy products, and opened an injectable-iron safety review.
Michael Levy, senior vice president, Digital & Innovation, USP, explains the digital supply chain in a preview of his upcoming CPHI Milan panel presentation, The Next Phase of Pharma Supply Chains.
