by
Loren Bonner, DOTmed News Online Editor | December 13, 2012
"We advise [companies] to be careful about training their non-U.S. facility managers so that the inspectors are not feeling that they have been rejected--this could prevent the shipped good already in transit from being admitted into the U.S." said O'Reilly.
According to the Regulatory Affairs Professionals Society, the new law is already driving companies to hire more compliance and quality staff members with experience dealing with the FDA.
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"The specific reason is that the change in inspections makes it far more high-risk than it's ever been before," said O'Reilly.
Extended deadline
The annual registration fee of $2,575 that all companies must now pay has been extended by one month until January, according to the FDA. The annual registration must now be paid before January 31, 2013, instead of December 31, 2013.
Connelly thinks the reason might be because of the short window for implementation. The legislation was approved in July and took effect Oct. 1.
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Ted Huss
Fees not new, but they sure are More! Productive Spending?
December 13, 2012 10:41
Just a start of more food for the government rathole of spending and funding employment and pensions of the bureaucracy. I guess a real optimist would expect highly productive results. Measured how?
Oh, sure, the FDA is necessary and logical, but the additional funding just permits a larger shell game. Any guarantee these funds will be spent directly for what they are intended?
Pardon my cynicism.
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