The Food and Drug Administration reports provided more data but were more difficult to use than the European Medicines Agency reports

European Medicines Agency updates on the review of Pandemrix and reports of narcolepsy.

The Committee agrees that further studies are necessary to understand the issue fully and that while the review is still ongoing there is no need for Europe-wide restrictions on the use of Pandemrix. The ongoing review will take some three to six months to conclude and will require new epidemiological research to establish conclusions on the possibility of a link between Pandemrix and narcolepsy.

Times ” More Difficult to Approximate Than

How many points do we need to approximate a given metric space S (e.g., a ball in the Euclidean space) with a given accuracy ε > 0? To be more precise, how many points do we need to reproduce the metric ρ(X, Y ) on S with an accuracy ε? This problem is known to be equivalent to the following geombinatoric problem: find the smallest number of balls of given radius ε that cover a given set S. A s...

Comparison of hydroxyethyl starch regulatory summaries from the Food and Drug Administration and the European Medicines Agency

This article aims to highlight the positions of the Food and Drug Administration and the European Medicines Agency regarding use and marketing of hydroxyethyl starch (HES) products, and how these have changed over recent years. In 2013, warnings from both agencies advised against use of HES in critically ill patients, including patients with sepsis, when several large randomized controlled tria...

Infanrix hexa and sudden death: a review of the periodic safety update reports submitted to the European Medicines Agency.

There have been a number of spontaneous reports of sudden unexpected death soon after the administration of Infanrix hexa (combined diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliomyelitis and Haemophilus influenza type B vaccine). The manufacturer, GlaxoSmithKline (GSK), submits confidential periodic safety update reports (PSURs) on Infanrix hexa to the European Medicin...

Prevention of Iodine Deficiency: Difficult to Implement, More Difficult to Sustain