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FDA Expected to Release Report in a "Few Weeks"
According to an AP release below, FDA has said it will release the results of its investigation of Mylan's plant in a few weeks. See the link:
http://www.forbes.com/feeds/ap/2009/08/04/ap6738395.html
Pharmalittle will report on that investigation whatever it does, or does not, find. We would be very glad if the company was fully exonerated.
Tuesday, August 4, 2009
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How can Mylan be exonerated when employees have admitted they were overriding security warnings? And why were they able to do so? Isn’t it the company’s responsibility to have a fail-safe system in place to ensure drugs are made to correct specs? How can it be that the 3rd largest generic drug company in the world has a security system that lets production workers decide the safety of medications? I doubt that this occurred without the knowledge or approval from above (and I don’t mean God).
ReplyDeleteOK, here's the rap...
ReplyDeleteIt was a few bad apples, and the system worked because it was caught, the company investigated, and no bad product got out (even over two years).
That's what we've heard so far.
I don't make the news.....
Off topic but I thought the attached NYT Article on medical ghost writing may be a topic of interest for the readers here.
ReplyDeletehttp://www.nytimes.com/2009/08/05/health/research/05ghost.html?ref=health
More on the continuing FDA investigation of Mylan
ReplyDeletehttp://www.post-gazette.com/pg/09217/988560-28.stm
Fierce Pharma has other good links to recent FDA changes at:
ReplyDeletehttp://www.fiercepharma.com/story/hamburg-honeymoon-could-aid-fda-reform/2009-06-17?utm_medium=nl&utm_source=internal