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Here’s the ribbon breaking ceremony picture. Let’s all hope this is a success and hopefully some new technology will enter the picture as well with remote batch monitoring of products manufactured in China and other locations in the world. There is only so much an in person visit can cover...
Posted to
The Medical Quack .... by Barbara Duck
by
The Medical Quack
on
11-19-2008
Filed under:
Filed under: Medically Related, Technology, Pharma/FDA News, Pharma, FDA, China, Outsourcing, Tainted Food, food contamination, food safety, busines intelligence software, server banks, import/exports, FDA inspections
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This was somewhat of a first for the US FDA to trust Chinese data. Shenzhen Chipscreen Bio sciences Ltd. was also awarded the Most Valued Partner for Roche R&D Center. Oncology drugs are one of their primary focuses, with individuals trained here in the US and returning to China to create their...
Posted to
The Medical Quack .... by Barbara Duck
by
The Medical Quack
on
11-15-2008
Filed under:
Filed under: Medically Related, Pharma/FDA News, Pharma, Biotech, FDA, Oncology, R and D, China pharma, Chipscreen, biosciences, HUYA
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I don’t think in view of the current events, there was a lot of choice here for the FDA, and we do need to know that the quality of both our food and pharmaceutical products is good. One thing in particular that springs to mind for me here here is perhaps some use of business intelligence for monitoring...
Posted to
The Medical Quack .... by Barbara Duck
by
The Medical Quack
on
11-13-2008
Filed under:
Filed under: Medically Related, Technology, Pharma/FDA News, Pharma, FDA, Tainted Food, food contamination, food safety, busines intelligence software, server banks, import/exports, FDA inspections
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I will once more mention a potential change of paradigms here with educating the public. Each patient who took the drug is unique. Do we have any information on other drugs they were taking at the same time? Groups will continue to advise against the use until the full facts are known...
Posted to
The Medical Quack .... by Barbara Duck
by
The Medical Quack
on
10-31-2008
Filed under:
Filed under: Medically Related, Pharma/FDA News, Other Items of Interest, drugs, healthcare, Pharma, PHR, FDA, Marketing, paradigms, personal heatlh records
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This actually a pretty good start and I have had my own campaign of sorts going on with getting the FDA up to speed, and they are definitely having to play catch up, as are some other government agencies. In prior posts I had written that some clinical studies were still being written in long hand...
Posted to
The Medical Quack .... by Barbara Duck
by
The Medical Quack
on
10-31-2008
Filed under:
Filed under: Medically Related, Pharma/FDA News, My Commentaries, healthcare, Education, Pharma, FDA, Personal Health Records, GSK, Consumer Healthcare, Drug Interactions
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Also as part of the settlement, all TV ads have to be approved by the FDA as well and they can delay their broadcast as well. In related news commercials are running sponsored by big Pharma thanking Congressmen for the their votes. The ads are sponsored by a nonprofit group called America...
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Reports of four experimental drugs held up at the FDA emerged in the first two days of this week. “ There’s almost certainly a bit of coincidence at work here, but it also seems to be one more sign of the tough safety climate at the agency these days .” Below are the 4 drugs. No doubt the...
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Everyone pretty much knows how the drug has been abused, so would an extended use help the cause? This looks to be a big potential loss for Abbott if they were counting on the money. BD The agency sent the drugmaker a ‘complete response letter,’ which is another way of saying its extended...
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We just read about China and now India by the end of the year. With all the recent problems in China with both food and Pharma products, they are first. There will be 10 offices total and as mentioned in the post regarding China, some of this is to be outsourced. This has really been...
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Whistle blowers today seem to be playing a role in the move towards transparency in more ways than one, not to mention the bounty that could be there if a case goes to court and wrongdoing is found to be the case. BD A New Jersey arbitrator ruled that a former Amgen sales rep can proceed with a...
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Anyone involved and R and D today can certainly take advantage of a Tablet PC. (I think those new fields reps for the FDA might even like this idea and concept too). Why walk around with an “ open pizza box” notebook, watch the video and see the difference and how tablets work while working, and...
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That might explain a couple odd stories of earlier this year, like the pilot program of the “Fake commercials” being tested, but there has also been an attempt to increase awareness at YouTube with FDA material as well, perhaps to even encouraging a bit of humor as I found on this video on YouTube, which...
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Not just India, but other countries as well. I have posted many articles on the blog referencing outsourcing over the last year or so and all of Big Pharma has interests in foreign countries including the strong possibility of phase 1 clinical trials. The one comment I have to make here...
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One more generic drug to be available soon in the US. BD Drug maker Glenmark Generics today said it has received United States Food and Drug Administration approval for marketing and distribution of Betamethasone Dipropionate Cream, used in the treatment of inflammatory diseases. Betamethasone...
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This story gets more worry some by the moment when you stop and think of where milk products are used. You see on the list some of our American branded products listed, manufactured outside the US, so this would indicate that even the company branding may not hold any value if a product is purchased...