Boyang Wang, Immortal Dragons, discusses how the FDA’s Expedited IND Pilot must prove efficiency as sponsors chase the fastest route to valid first-in-human data.
News|Articles|March 15, 2020
A Case Study in Pharmacopoeia Compliance: Excipients and Raw Materials
Author(s)J. Mark Wiggins, Joseph A. Albanese
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.
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