FDA to Streamline Regulations in Light of 21st Century Cures Act

HealthITAnalytics – The sprawling 21st Century Cures Act aims to bring changes to many areas of the healthcare industry, from drug trials and EHR interoperability to precision medicine and telehealth

While the law does contain specific directions for stakeholders and policymakers to implement certain new programs and guidelines, perhaps its biggest influence will be on the rules that are rethought or relaxed in an effort to streamline innovation.

Since the FDA plays such a pivotal role in regulating new medical devices, therapies, and medication, the agency will be taking a second look at some of its processes in order to prevent barriers to innovation or unnecessarily high costs in light of the new law, said Commissioner Scott Gottlieb, MD, in a recent blog post.

“We’re at a point in science where new medical technologies hold out the promise of better treatments for a widening number of vexing conditions,” he wrote. “To build upon such opportunities, FDA will soon unveil a comprehensive Innovation Initiative.”

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