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Search results for "Food and Drug Administration (FDA)"
- Food and Drug Administration (FDA)
- Governmental Reporting
Tools/Toolkit > Fact Sheet/FAQs
FDA Consumer Health Information. Silver Spring, MD: US Food and Drug Administration; February 27, 2009.
This fact sheet provides information for consumers about how to report adverse drug events and product complaints to the US Food and Drug Administration (FDA) through the Consumer Complaint Reporting system and MedWatch.
Shuren J. Federal Register. October 23, 2008;73:63153-63157.
This announcement invites field review of proposed information elements to be included in a Food and Drug Administration portal designed to collect drug- and product-related adverse event reports. The comment collection period is now closed.
Tools/Toolkit > Fact Sheet/FAQs
Center for Drug Evaluation and Research, US Food and Drug Administration.
This Web site provides information on and access to quarterly reports and an interactive dashboard of medication-related incidents culled from FDA's Adverse Event Reporting System (FAERS) database and identifies potential safety issues.
FDA preliminary public health notification: update of information about Ralstonia spp. associated with Vapotherm Respiratory Gas Administration device.
Schultz DG. Rockville, MD: Center for Devices and Radiological Health, Food and Drug Administration; December 20, 2005.
This safety alert for health care practitioners discusses bacterial contamination of gas devices and recommends alternatives be used until the source of the contamination is identified.
Risk of electromagnetic interference with medical telemetry systems operating in the 460-470 MHz frequency bands.
MedWatch Safety Alert. Silver Spring, MD: US Food and Drug Administration; November 16, 2005.
This announcement notifies health care practitioners of possible interference with medical alarms and patient monitoring systems caused by mobile radio transmitters.
Journal Article > Study
Wysowski DK, Swartz L. Arch Intern Med. 2005;165:1363-1369.
This study analyzed reports of suspected adverse drug events (ADEs) submitted to the U.S. Food and Drug Administration (FDA). Using more than 30 years of collected data, investigators discovered nearly 2.3 million case reports for the 6000 drugs in the database. These reports resulted in additional safety warnings, a greater list of known ADEs with specific drugs, and a small percentage of drugs pulled from the market. The authors advocate for continued vigilance and reporting to ensure the safety of drugs prescribed to patients.
Web Resource > Government Resource
US Food and Drug Administration.
MedWatch, the Food and Drug Administration (FDA) Safety Information and Adverse Event Reporting Program, serves both health care professionals and consumers of health care products. The site shares safety information about medications and medical products that are regulated by the FDA.
Web Resource > Multi-use Website
Human Factors Engineering Team, Center for Devices and Radiological Health, Office of Communication, Education, and Radiation Programs (OCER), Division of Device User Programs and Systems Analysis (DDUPSA), 1350 Piccard Drive, HFZ-230, Rockville, MD 20850.
Human factors engineering (HFE) helps improve human performance and reduce the risks associated with use error. The U.S. Food and Drug Administration (FDA) works with manufacturers to ensure the application of HFE in the design of new products. In addition to providing information on these design issues, this site facilitates the reporting of unsafe incidents with medical devices.