The Food and Drug Administration, with regulatory responsibility for product labeling, has been concerned that drug, device and biologic labeling may not meet the needs of the health care professionals who must select and use these products for patient diagnosis and care. In an effort to evaluate the usefulness of current medical product labeling to its target population, the FDA has examined health professionals' use of and preferences concerning that labeling in a number of qualitative research initiatives.
The Center for Drugs Evaluation and Research (CDER) has conducted focus groups and a survey of physicians to examine these issues. In October 1995, a public meeting was held to present the findings and the labeling prototype developed by CDER to address the findings. To obtain more information on the CDER initiative, request Docket #95N-0314 through the Freedom of Information (FOI) process.
The Center for Biologics Evaluation and Research (CBER) has surveyed practitioners on their use and perceptions of the vaccine package insert, gathering information that supported the CDER research.
"The Draft Initial Report on Medical Device Labeling: Health Care Practioners' Medical Device Information and Labeling Needs -- Results of Qualitative Research" presents the findings of the investigations conducted by the Center For Devices and Radiological Health, FDA, into labeling use and preferences of health care practioners. We invite your comments on the issues raised by the research. Please send comments to Patricia Kingsley.
"The Draft Initial Report on Medical Device Labeling: Health Care Practioners' Medical Device Information and Labeling Needs -- Results of Qualitative Research" is available as a PDF.