Day: March 7, 2019

Medical device manufacturers will be able to send their proposed actions to address audit findings to FDA before formally implementing them, thereby avoiding unnecessary back and forth with the FDA. An FDA 483 lists all the findings of non-compliance at the audited site with the requirement that the manufacturer address all findings adequately within a … Read more

Patient recruitment issues afflict all clinical trials and a recent study shows that the main reason for such performance is not the availability of enough participants but the trial design. More than two-thirds of the participants either do not find trials or do not meet the strict inclusion criteria. Another 15 percent are not enrolled … Read more