Newsletter - November 19, 2015
Is the FDA at Fault for Allowing Drugs Made in India Despite Multiple GMP Violations?
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 countries. We received more than 100 comments that our analysis was too generalized, and that the actual citations of non-compliance point to a trend for more serious violations. Read More..
Clinical Trial Results Remain Under-Reported Publicly
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 trials were used to support the market approval of 15 drugs; only about 54 of these trials were published in peer reviewed journals. Read More..
Is the FDA at Fault for Allowing Drugs Made in India Despite Multiple GMP Violations?
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 countries. We received more than 100 comments that our analysis was too generalized, and that the actual citations of non-compliance point to a trend for more serious violations. Read More..
Clinical Trial Results Remain Under-Reported Publicly
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 trials were used to support the market approval of 15 drugs; only about 54 of these trials were published in peer reviewed journals. Read More..
