Month: February 2015

Why is FDA dropping ball on ‘superbug’?

Last week, UCLA Medical Center notified 179 patients that it had potentially exposed them to a fearsome “superbug,” and urged them to get tested. The hospital accidentally infected seven people in procedures involving specialized endoscopes, called duodenoscopes, that proved difficult to thoroughly clean. Two of the people died. The “superbug” at issue — carbapenem-resistant Enterobacteriaceae, or CRE …

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Drugmaker tries again to win approval for “female Viagra”

WASHINGTON — The makers of a twice-rejected pill designed to boost female libido are resubmitting their drug to federal health regulators, following a recent lobbying blitz by politicians, women’s groups and consumer advocates aimed at pushing it onto the market. Sprout Pharmaceuticals said Tuesday it is refiling its application for the drug, flibanserin, adding new information requested by …

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Potential Signals of Serious Risks/New Safety Information Identified from the FDA Adverse Event Reporting System (FAERS)

What is FDA posting? The following reports list potential signals of serious risks/new safety information that were identified using the FAERS database during the indicated quarter. Data from AERS was moved to FAERS for the launch of FAERS on September 10, 2012. The appearance of a drug on this list does not mean that FDA …

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Recent Warning Letters – Pharmaceutical & Medical Device Regulatory Update, Vol. II, Issue 2

Since we last reported on enforcement actions in December 2014, FDA posted warning letters to drug and device manufacturers, as well as one fertility center, for violations related to CGMP (“Current Good Manufacturing Practices”), QSR (“Quality Systems Regulations”), MDR (“Medical Device Reporting”), selling unapproved animal drugs, clinical investigations, and deviations from the regulations for human …

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