After the recent issuing of three final guidance’s by the US FDA, there have been many speculations. Some supporter favor these final documents, while others fear the documents led to the risk of “taking a copycat product.” There are two main groups that reached out...
Set to release Tuesday, April 28, FDA plans to issue a draft guidance document regarding its current policy of accepting clinical trial data performed outside the United States in support of medical device premarket submissions. To be clear, this document is not...
Pearl Pathways is excited to sponsor Q1 Productions’ and attend its upcoming IVD conference on Clinical Affairs and Regulatory Approvals for Diagnostics. The conference provides an excellent opportunity to network with industry experts and gain additional insight on...
In order to present related information to a clinical study and acquire and document informed consent, electronic systems and processes such as text, audio, and graphics are increasingly being employed. According to FDA per their new draft guidance, this is referred...
Conducting clinical research is extremely time consuming given the extensive requirements necessary to begin a clinical trial. Protocols must be adhered to, results must be extensively recorded, and most importantly, patients must be protected complying with Section...