FDA has released a new final guidance document supporting clinical studies of new medical devices under their Investigational Device Exemption (IDE) regulations. In order to conduct clinical trials on investigational products, medical device companies must submit an...
On August 8, 2013, Gretchen Bowker, co-founder and COO of Pearl Pathways, will host a webinar on ComplianceOnline.com reviewing the similarities and differences in the regulatory paths and requirements for drugs, biologics and medical devices. It will discuss the...
Pearl Pathways’ co-founder and COO, Gretchen Miller Bowker, will be leading a discussion presented by ASQ Biomedical Division covering the similarities and differences between INDs and IDEs and everything in between. The discussion will be held at the...
