Public Awareness
Recall:FDA warns about painkiller mix-up in Excedrin, Bufferin
January 9, 2012 | No comments
The Associated Press reported a warning from the FDA about a potential mix-up between powerful prescription pain drugs and common …
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FDA issues Warning Letters for Misleading Advertising of Lap-Band
December 13, 2011 | No comments
The FDA issued warning letters for misleading Lap-Band advertising which the Agency states lacks information on the risks of gastric …
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Personal Health Information (PHI) in Corrective and Preventive Action (CAPA)
October 27, 2011 | No comments
Corrective and Preventive Action (CAPA) is a component all medical device facilities, whether importer, distributor, or manufacturer, must comply with. …
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Medical Device Pre-Market Programs: An Overview of FDA Actions
October 20, 2011 | No comments
Nearly two years ago, the FDA’s Center for Devices and Radiological Health (CDRH) recognized the need to re-evaluate and modernize …
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Baby Products with SIDS Prevention Claims
October 17, 2011 | No comments
Companies can inadvertenly fall under the FDA’s authority by how they market themselves. Medical devices include any claim to “cure, treat, …
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Decorative/Fashion Contact Lenses – Know the Risks
October 12, 2011 | No comments
Advice from the FDA just in time for Halloween. Pseudomonas eye infection. Image courtesy of Thomas Steinemann, MD and MetroHealth …
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