Regulatory News In Brief
This article was originally published in The Gray Sheet
Executive Summary
FDA issues two FDASIA-mandated reports to Congress – one on underrepresented subpopulations and the second on small businesses. More regulatory news.
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CDRH Launches ‘Health Of Women’ Program; Research Agenda To Focus On Ortho, Cardio Devices
The device center plans to develop a research roadmap to explore sex-based differences in outcomes to musculoskeletal and cardiovascular disease devices, as well as devices targeting diseases specific to women. CDRH launched the effort as part of its new “Health of Women” initiative at a workshop last week.
Lab-Developed Test Regs In Spotlight With Citizen Petition, Hamburg Speech
The American Clinical Laboratory Association filed a citizen petition with FDA June 4 reiterating and formalizing its long-held opposition to FDA regulating laboratory-developed test services. The petition closely followed a speech from FDA Commissioner Hamburg emphasizing plans to do just that.
FDA’s James Valentine Discusses New Patient Network Website
The goals of the agency’s Patient Network website, which went live in late April, are to educate and to get patients and patient advocates involved in the FDA regulatory process.