UPDATED
FDA delivers warning to Chinese company after no response to Form 483
US FDA sends a warning letter to Yino, after the company failed to provide a response to issues raised in a Form 483 regarding relabeling of API.
Archives for September 10, 2019
Investigator satisfaction and central lab performance: Report
Fewer investigators cite patient recruitment as a top challenge in a recent report which finds investigators also more willing to participate in future clinical trials if working with a preferred central lab.
Life Image launches ‘Real World Imaging’ offering to overcome RWE challenges
The network for clinical and imaging data launches a new ‘Real World Imaging’ offering to complement existing real world evidence – and help overcome the challenges of bias and homogeneity, says CEO.
FDA approves Omega Laboratories for manufacturing
Sagent announces the approval of its subsidiary’s facility in Canada to manufacture small molecule drug products for the US market.
Vineti, Cryoport partner to extend end-to-end cell therapy logistics offering
A collaboration between Vineti and Cryoport aims to extend supply chain services as the cell and gene therapies space continues to scale.