Archives for 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.

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.

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 has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has identified a causal relationship between the drug and the listed risk. If after further evaluation the FDA determines that the drug is associated with the risk, it may take a variety of actions, including requiring changes to the labeling of the drug, requiring development of a Risk Evaluation and Mitigation Strategy (REMS), or gathering additional data to better characterize the risk.

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 cells, tissues, and cellular and tissue-based products.