Current Edition

The Real World of Medicine: Regulatory Perspectives on the Pragmatic Data to Support the Approval of New Drug Products

Regina Ballinger, Senior Manager of Regulatory Intelligence with Thomson Reuters, shares her views on what is known as FDA’s “Statute.” A pillar of the FDA’s mission, the statute speaks to requirements of substantial evidence of efficacy as the bar for approving new drug products. When speaking on the approval of medical devices, this becomes “reasonable assurance of safety and efficacy.” Semantics aside, the FDA is looking to tap sources of valid scientific data to support the approval of medical products in the US.