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Search results for "Food and Drug Administration (FDA)"
- Food and Drug Administration (FDA)
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.
McNeil Consumer & Specialty Pharmaceuticals announces nationwide recall of Children's Tylenol Meltaways - 80 Mg, Children's Tylenol Softchews - 80 Mg and Jr. Tylenol Meltaways - 160 Mg [press release].
Fort Washington, PA: McNeil Consumer & Specialty Pharmaceuticals; June 3, 2005.
This news release announces the recall of several Tylenol children's medications. The packaging and labeling for these medications may be confusing and lead to overdosing.
FDA public health notification: MRI-caused injuries in patients with implanted neurological stimulators.
Schultz DG. Rockville, MD: Center for Devices and Radiological Health, Food and Drug Administration; May 10, 2005.
In response to reports of injuries in patients with implanted neurological stimulators who underwent magnetic resonance imaging procedures, the Food and Drug Administration suggests related precautions for radiology personnel and physicians.
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.
Audiovisual > Audiovisual Presentation
U.S. Food and Drug Administration, Rockville, MD.
FDA Patient Safety News is a televised series for health care personnel. The monthly series runs on satellite broadcast networks targeting hospitals and other medical facilities across the country. It features information on new drugs and medical devices, on U.S. Food and Drug Administration (FDA) safety notifications and product recalls, and on ways to protect patients when using medical products.
Web Resource > Database/Directory
Rockville, MD. Food and Drug Administration.
This website provides information to consumers about health-related issues of current interest to the general public.
Legislation/Regulation > Government Resource
US Food and Drug Administration, HHS. Final rule. Fed Regist. February 26, 2004;69(38):9119-9171.
The US Food and Drug Administration (FDA) requires certain human drug and biological product labels to contain bar codes. The rule aims to reduce the number of medication errors by allowing health care professionals to use bar code scanning equipment for necessary verification. This protects against an incorrect drug administration. Effective date: April 26, 2004.
Journal Article > Study
Roberts R, Rodriguez W, Murphy D, Crescenzi T. JAMA. 2003;290:905-911.