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Months of negotiations have come to an end as the top Republican and Democrat on the Senate Health, Education, Labor and Pensions (HELP) Committee finally introduced their comprehensive overhaul of the nation’s drug safety efforts.
There is growing consensus that doctors need to work more closely with heart device manufacturers to establish guidelines for managing patients implanted with devices at risk for malfunction.
German pharma company TeGenero filed for bankruptcy protection in a court in W
rzburg, Germany, on July 4 — less than four months after the UK-based clinical trial of its flagship immune-boosting drug TGN1412 caused severe adverse reactions in six healthy male volunteers.
A class of widely prescribed inhalers for people with chronic obstructive pulmonary disease (COPD) that includes well-known brands such as Advair, Serevent and Foradil doubles the risk of respiratory death, while a little-used alternative actually reduces the likelihood of such fatalities, according to a study to be published in an upcoming issue of the Journal of General Internal Medicine.
The Australia Therapeutic Goods Administration TGA) and the New Zealand Medicines and Medical Devices Safety Authority (Medsafe) have unveiled a draft rule on the proposed regulatory scheme for medicines under the planned merger of the two agencies.
TeGenero, the German pharmaceutical startup whose UK-based clinical trial for its immune-boosting drug TGN1412 caused severe adverse reactions in six healthy male volunteers, has announced that it filed for bankruptcy protection in a court in Wurzburg, Germany, on July 4.
A bill under consideration in the Massachusetts state legislature offers patients the option of giving their informed consent before being treated with reused, or "reprocessed," devices designed for single use only.
Baxter Healthcare has signed a consent decree with the FDA
related to violations of current good manufacturing practices (cGMPs) in making two brands of infusion pumps, the agency said June 29.
The first year of the FDA’s Drug Safety Oversight Board (DSB)shows that the panel can help improve and accelerate drug reviews by providing a forum where senior officials can consult on drug safety issues, according to an agency official.