Day: November 19, 2015

Three bioethicists, one each from NYU, Harvard and Yale, published a review of public reporting of clinical trial data used to support FDA approval by 10 major pharma companies of 15 new drugs in 2012. It was found that results from only about a third of the clinical trial trials were published. A total of 318 clinical … Read more

It seems we stirred the hornet’s nest when we posted that Indian drug manufactures are not as bad in GMP compliance as the prevailing perceptions the media would have us believe. A review of the FDA’s Inspections database indicates that auditors find similar numbers of major and minor findings in India as at sites located in other … Read more