Chinese API site inspection prompts US FDA warning
The US FDA has issued a warning letter to Chinese API maker Jilin Shulan Synthetic Pharmaceutical Co., citing lax electronic data security and inadequate batch records.
Archives for June 4, 2018
Six-month serialization countdown in US: Think strategy and lead times, says CPO
Drugmakers should allow time to test packaging and implement changes if needed, before the November DSCSA deadline, says contract packaging organization.
Demand for pathology services sparks PPD, NeoGenomics alliance
PPD is teaming up with NeoGenomics Laboratories in response to increasingly complex clinical trials and demand for pathology services, says exec.
Syngene teams with immuno-oncology firm to provide ‘greater value-added services’
Syngene International has inked a non-exclusive partnering agreement with the emerging immuno-oncology company Zumutor Biologics after collaborating for more than a year.