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THE OFFICIAL SUNSET RESOURCE GROUP BLOG |
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FDA To Get 30-50% Budget Increase. |
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Posted by Administrator on 2009-06-18 19:13:50 |
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FDA BUDGET INCREASE 30-50%
Interesting talk w FDA staff-Lots of new inspectors & General Counsel is signing off on warnings & actions much faster-expect more activity!
In an informal conversation with a current FDA staff member we learned that the agency is expecting to issue many more warning letters and to follow up on those warnings much more quickly. Why is this? First, last fall the agency hired hundreds of new inspectors. This was in response to the many issues that had come up previously—adulterated heparin and food ingredients to name only two.
The second and probably most important reason we should expect to see much more enforcement activity from FDA is that with the change in administration, the Health and Human Services Office of General Counsel, which must approve every warning letter and other action, is processing these actions at lightening speed. In the past, warning letters could wait six months or more for approval. However, a warning letter that went out in early June 2009 was the result of an inspection that took place in mid-May 2009.
The person I spoke with was delighted with these changes and hopeful that FDA will be able to readily fulfill its mandate to protect public health, particularly since the agency is expecting a 30 to 50% increase in their operating budget.
Since no one is perfect, what does this mean for you and your company? Do you need to tighten up your GMP processes—perhaps review SOPs? Is it time to review your marketing programs and labeling? Contact us if you think you need to do anything other than relax and enjoy summer! |
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Comments: 2 |
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1. So you think the FDA is going to be trouble? Wait until you see what the HEALTH CARE plan will do...
We're going to pass a health care plan
written by a committee whose head says he doesn't understand it,
passed by a Congress that hasn't read it but exempts themselves from it,
signed by a president who also hasn't read it, and who smokes,
with funding administered by a treasury chief who didn't pay his taxes,
overseen by a surgeon general who is obese, and
financed by a country that's nearly broke.
What possibly could go wrong? |
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Posted by: admin on 2009-10-26 14:19:14 |
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2. This says it all as follow up to our voice in the wilderness editorial posted in 2006 about what these characters have been up to while their stock went from 30 to 130 at the expense of farmers and consumers world wide. I wonder how much they donated to lobby groups for both parties to look the other way. http://finance.yahoo.com/news/AP-IMPACT-Monsanto-seed-apf-4027376931.html?x=0&sec=topStories&pos=6&asset=&ccode |
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Posted by: sunsetdemo on 2009-12-13 18:15:30 |
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