“The FDA works in mysterious ways,” or maybe, “The answer you get kinda depends on which staffer you talk to and what kind of mood they’re in that day,” is how we’ve heard research professionals describe the Food and Drug Administration. Among other responsibilities, the FDA manages the research processes that lead to the approval of new drugs, devices, and biologics.
Science magazine recently published an article taking a close look at how the FDA oversees clinical trial conduct, and found oversight and enforcement to be surprisingly, um, light-handed. Read the whole article here. To give you an idea of what this team found, the article’s title is, “FDA’s own documents reveal agency’s lax, low, and secretive oversight of clinical research.”