Medical Innovation Exchange

RWD

Key Barriers to RWD Adoption

Key Barriers to RWD Adoption     Complex data curation and lack of knowledge on patient care settings and behaviors are among the key barriers to widespread adoption of real world data in life sciences, according to the results of a recent survey commissioned by Komodo Health and conducted by Frost & Sullivan. The survey, which was …

Key Barriers to RWD Adoption Read More »

FDA Issues Updated Draft Guidance on Use of Real World Evidence

FDA Issues Updated Draft Guidance on Use of Real World Evidence     On December 18, the FDA issued a draft guidance, Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices. When final, this guidance will supersede Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices, issued August 2017. The new draft guidance …

FDA Issues Updated Draft Guidance on Use of Real World Evidence Read More »

FDA Seeks Input on Advancing Use of Real-World Data and Evidence

FDA Seeks Input on Advancing Use of Real-World Data and Evidence     The FDA is seeking input from stakeholders on how it should use user fee funding for engaging with external organizations, other than the National Evaluation System for Health Technology (NEST), to support premarket Real-World Evidence. Under the fifth reauthorization of the Medical Device …

FDA Seeks Input on Advancing Use of Real-World Data and Evidence Read More »

FDA Highlights Exemptions for Real World Data-identified AEs

FDA Highlights Exemptions for Real World Data-identified AEs     On December 20, the FDA updated its Exemptions, Variances, and Alternative Forms of Adverse Event Reporting for Medical Devices web page to remind manufacturers that it has granted several exemptions to its Medical Device Reporting (MDR) requirements related to events identified in certain real-world data (RWD) …

FDA Highlights Exemptions for Real World Data-identified AEs Read More »