On May 17, 2016, FDA issued Draft Guidance for Industry on Use of Electronic Health Record Data in Clinical Investigations (“Draft Guidance”). This Draft Guidance builds on prior FDA guidance on Computerized Systems Used in Clinical Investigations and Electronic Source Data in Clinical Investigations, and provides information on FDA’s expectations for the use of
combination products
Five Issues to Consider While Reviewing the Clinical Trial Registration Proposed Rule
By Daniel Gottlieb on
Posted in FDA
Earlier this week the Department of Health and Human Services (“HHS”) published its long awaited notice of proposed rulemaking regarding the registration of clinical trials. The most significant change that would result from implementation of the proposed rule, and the one getting the most press, is the new requirement that results data be …
FDA Jurisdictional Determinations Should Not Be a Riddle, Wrapped in a Mystery, Inside an Enigma
By Daniel Gottlieb on
Posted in FDA, Medical Device
Upon learning that FDA had lost another round in its battle to classify Diphoterine® Skin Wash (DSW) as a combination product with a drug primary mode of action and that Prevor, DSW’s manufacturer, was still fighting this issue nearly six years after it submitted its initial premarket notification for DSW, I turned into a five-year-old…