Kathleen Sanzo


FDA Issues Final Rule on Data Acceptance from Clinical Investigations for Medical Devices

March 07, 2018

The FDA published a final rule on FDA’s standards for accepting data from clinical investigations for medical devices on February 21.

What Pharma Companies Need to Know About FDA's New Draft IVD Guidance

February 12, 2018

The FDA's new draft IVD Guidelines will need to be factored into how pharma clinical trial sponsors use IVDs in a clinical trial, study design, timeline for protocol development, IND submission, and study initiation.