Medical Innovation Exchange

Medical Device

AHRQ Announces Real World Data Competition for HCOs

AHRQ Announces Real World Data Competition for HCOs     On September 27, the Agency for Healthcare Research and Quality (AHRQ) announced a new challenge competition to explore the feasibility, resources and infrastructure needed to integrate real-world healthcare system data into AHRQ’s systematic review findings to improve healthcare practice. The top award winner could earn up …

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Ethical Considerations for Children in Clinical Investigations: FDA Publishes New Draft Guidance

Ethical Considerations for Children in Clinical Investigations: FDA Publishes New Draft Guidance     The FDA has published a new draft guidance that outlines its current views regarding ethical considerations for clinical investigations of medical products in children. The guidance seeks to balance the need to obtain data on the safety and effectiveness of drugs, biological …

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A Single Source of Truth Helps Regulatory Teams

A Single Source of Truth Helps Regulatory Teams     Regulatory teams participate in every step of bringing a medical device or drug to market. Because of the essential role they play, these teams need advanced tools to keep pace with the latest regulatory bodies and standards. Legacy technology that siloes data across different pillars isn’t …

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OPDP Outlines New Research

FDA published notice recently that the Office of Prescription Drug Promotion (OPDP) was proposing some new research related to the promotion of medicines by pharmaceutical companies. The research was new (kind of) but the direction was more of the same old focus – direct-to-consumer advertising (DTC). First, just a note on why the research is …

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FDA Announces Funding Opportunities for Medical Device Development Tools

FDA Announces Funding Opportunities for Medical Device Development Tools     The FDA Center for Devices and Radiological Health (CDRH) has announced new funding opportunities to support small businesses in developing innovative medical device development tools (MDDTs). The MDDT program was created in collaboration with the National Institutes of Health’s (NIH’s) National Institute of Drug Abuse …

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