The FDA has granted priority review status for pegcetacoplan (Empaveli) to treat two rare kidney diseases that can lead to kidney failure. Up until now, there hadn’t been any drugs approved ...

The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...

The aim of the EU Clinical Trials Regulation (CTR) is to harmonise the clinical trial regulation process across 27 countries and have an 80-day approval timeline, stated Dr. Martine Dehlinger-Kremer, ...

Administrative Aspects of Molecular Diagnostics—Oversight, Regulatory Approval Process, Clinical and Operational Workflows, and Payment Models The following represents disclosure information provided ...