US Food and Drug Administration (FDA) officials asserted at a 26 April Generic Drug Forum (GDF) that firms with weak quality cultures are more susceptible to submit abbreviated new drug applications ...
"For example, the computer in [Pan's] quality unit area did not have controls to restrict access and prevent unauthorized changes to data files and folders," FDA writes. In light of these issues, FDA ...
Cathy Burgess, Benjamin Wolf, Jong Ho "Philip" Won, Ph.D. The Food and Drug Administration’s (FDA) recent rejection of all study data from Mid-Link Testing highlights the importance of using reliable, ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results