Comments of the National Center for Health Research On proposed order “Physical Medicine Devices: Reclassification and Renaming of Shortwave Diathermy of All Other Uses”

To view as PDF, click here. Division of Dockets Management Food and Drug Administration 5630 Fishers Lane, Room 1061 (HFA-305) Rockville, Maryland 20852 May 21, 2014 Comments of the National Center for Health Research On proposed order “Physical Medicine Devices: Reclassification … Continue reading

Statement of Laurén Doamekpor on the Importance of Including Women, Minorities, and the Elderly in Studies of the Safety and Effectiveness of New Drugs and Devices (FDASIA Section 907 Hearing)

The responsibility of collecting sufficiently representative demographic subgroup data sits solely on the shoulders of device and drug companies. The companies know how to persuade – they do it everyday in commercials. Similarly, if they identify persuasive incentives for patients to participate in studies, and minimize disincentives, patients will participate and be available for follow-up. Continue reading