Current Status and Considerations for Clinical Studies In an effort to promote innovation while protecting the population at large, the U.S. Food and Drug Administration (FDA) has for several years been on a course to revise the existing regulatory pathway surrounding the 510(k) process for medical devices. One topic of concern focuses upon clinical data.
GxP Lifeline: Good Clinical Practice: From Review to Application >>
As clinical research professionals, we often hear phrases like, "It's in the regs!" Or, "It's GCP!" At times, it may seem as though by classifying our actions as "GCP," we wave a magic wand that ensures regulatory compliance. But what is GCP, and what does it mean to be GCP compliant? In order to take "good" to "great," it is important understand the conceptual framework that supports good clinical practice and be able to apply that understanding in daily research practice.
