
— Bring in the enforcements: The US Food and Drug Administration (FDA) might soon have third-party inspectors monitoring Genzyme’s factory in Allston, Massachusetts. After a few manufacturing problems at the company, the FDA might issue a consent decree, establishing an inspectorate to oversee quality control. (FiercePharma)
— Are we there yet? No, wait a little longer. According to a review of clinical trials, those that are stopped early — often because the benefits of treatment are already seen — underestimate a given treatment’s risks. Study authors compared 91 shortened trials with more than 400 trials that ran their full course, and found that truncated trials underestimate relative risk by 29%, on average.
— Researchers have looked at stratified segments of the US population such as ‘black middle America’ and ‘Northland low-income rural whites’ to get a better picture of life expectancy. According to the study, southern rural blacks seem most affected by the four risk factors analyzed: smoking, high blood pressure, high blood sugar, and high body fat.
— A little test, come too late? The FDA has approved IntelligentMDx’s molecular diagnostic test for H1N1, which the company claims is the first of its kind to make it through. The approval, however, comes under emergency authorization, and the pandemic’s emergency status is set to expire April 26, according to the Cambridge, Massachusetts-based company. (Xconomy)
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