For the sixth year consecutive year, IMARC is presenting its Top 10 Warning Letter findings for your review.
Topics: BIMO Metrics, Top 10, FDA, Warning Letters

You want to keep your trial on track, but physical distancing and travel restrictions have made it difficult. Fortunately, IMARC has experience providing remote services.
For the sixth year consecutive year, IMARC is presenting its Top 10 Warning Letter findings for your review.
Topics: BIMO Metrics, Top 10, FDA, Warning Letters
We ran across this article in Fierce Medical Devices and thought we would share it. The article highlights the Top 10 device and diagnostic approvals for 2012. Every year companies submit their Premarket Approval Application (PMA), the application submitted to the FDA for approval of a Class III device, to FDA seeking premarket approval. This application can sometimes prompt FDA to inspect clinical sites, but ultimately the hope for a sponsor is approval.
Topics: Top 10, FDA Approvals, Device and Diagnostics