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Leading Medical Groups Advise Against Avandia – FDA to Research – Education Needed

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...

Published Fri, Oct 10 2008 2:27 PM by The Medical Quack

Filed under: Medically Related, Pharma/FDA News, Other Items of Interest, drugs, healthcare, Pharma, PHR, FDA, Marketing, paradigms, personal heatlh records

In Two Days, Four New Drugs Stall at FDA

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...

Published Wed, Oct 10 2008 12:36 PM by The Medical Quack

Filed under: Medically Related, Pharma/FDA News, drugs, Pharma, FDA, Ranbaxy, Medications, Drug Safety

FDA will open inspection office in China this year

Some of the duties will be outsourced, but under the control of a local office, and portions of this provision will need an act of Congress, so I might guess now’s the time, or after the election maybe to tackle this issue. I would also like to...

Published Thu, Oct 10 2008 10:40 PM by The Medical Quack

Filed under: Medically Related, Pharma/FDA News, My Commentaries, drugs, FDA, China, Outsourcing, Food products, Congress Pharma

Amgen Sales Rep Can Pursue Wrongful Firing Suit

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...

Published Thu, Oct 10 2008 4:47 PM by The Medical Quack

Filed under: Pharma/FDA News, Other Items of Interest, drugs, Pharma, FDA, Marketing, Amgen, Whistle Blower

Medco To Begin Working with the FDA – Pharmacogenomics Reporting

This article states part of the reporting system will include information on the willingness of a doctor to use genetic testing, well first of all we need to help the doctors to bring this full circle with the integration into the clinical side of this...

Published Mon, Oct 10 2008 1:35 PM by The Medical Quack

Filed under: Medically Related, Pharma/FDA News, Genomics, drugs, Education, FDA, Pharmaceuticals, Pharmacogenomics, DNA Testing

FDA: Tiny Bit of Melamine OK in Most Foods But we Still need better labeling and shipping documentation

We still need more labeling and the ability for consumers to identify products when recalls are sent out. Look a the Heparin recall that failed, and that was a drug. In a recent post I had some suggestions that can be read here, including disallowing...

Published Fri, Oct 10 2008 2:39 PM by The Medical Quack

Filed under: Medically Related, Pharma/FDA News, drugs, FDA, tainted milk, Melamine, Commerce, Transportation Shipping and Receiving, Food products

FDA Bans Import of Meds From Ranbaxy

More can be read here as well. The issue goes back to a raid in 2006 of a US warehouse in New Jersey. If the pills were a problem, why were they allowed to continue to ship with allegations that factory test records were falsified. Well...

Published Tue, Sep 09 2008 8:08 PM by The Medical Quack

Filed under: Medically Related, Pharma/FDA News, drugs, FDA, Generic Drugs, Ranbaxy

What Impact does a Warning from the FDA have with Investors, Physicians, Patients?

It seems not a week goes by without a warning being issued from the FDA, so this looks to be a sign of the times, not to put anyone out of business, but to create an awareness. This is transparency folks and the warnings will keep on coming, so...

Published Sun, Sep 09 2008 2:57 PM by The Medical Quack

Filed under: Medically Related, Pharma/FDA News, Genomics, drugs, Investors, Pharma, FDA, Warnings, Personalized Mediicine

FDA hires 1,300 new doctors and scientists

The drug evaluation department has the largest increase, and oncologists were difficult to find as most make more money on the outside. I wonder if they can find enough for the drug side of the business, as it is changing every day with new applications...

Published Fri, Sep 09 2008 12:38 AM by The Medical Quack

Filed under: Medically Related, Pharma/FDA News, Other Items of Interest, drugs, Pharma, FDA, Employment

Illegal Drugs Finding their way into research and development

Interesting article with some good background information about drugs that are close to or are related to the "street drugs" as we know them. There are definitely a number of researchers who want to delve into this further, but with bad...

Published Thu, Sep 09 2008 4:44 PM by The Medical Quack

Filed under: Medically Related, Pharma/FDA News, Other Items of Interest, drugs, healthcare, Pharma, FDA, DEA, R and D, street drugs

Judge unseals secret Zyprexa papers - More Side Effects News

More marketing and potential hidden information seems to be making it's way to front, and interesting now on who wants to be reimbursed, insurance companies among the group. This appears to be an all out battle ground here. Weight gain...

Published Mon, Sep 09 2008 12:52 PM by The Medical Quack

Filed under: Medically Related, Insurance, Pharma/FDA News, drugs, Pharma, FDA, Law Suit, Zyprexa, Lilly

FDA Index on Drug Alerts

I spent a little time looking around today and there are many "red stars" on this page, which indicate a safety alert from the FDA. Safety alerts come in all shapes and sizes and a red start does not mean to stop taking medications by...

Published Sun, Sep 09 2008 12:26 PM by The Medical Quack

Filed under: Medically Related, Other Items of Interest, My Commentaries, drugs, Pharma, FDA, Drug Information, Warnings

The Changing Face of Research and Development with big Pharma

Many of the generic manufacturers started years back with knock off drugs to sell locally in India, but now the game is changing to where US Pharma is using some of the talent, which costs less than R and D individuals here in the states, to further develop...

Published Fri, Sep 09 2008 6:58 PM by The Medical Quack

Filed under: Medically Related, Pharma/FDA News, Genomics, drugs, Pharma, Biotech, Cancer, FDA, Budgets, R and D, Alzheimers, Outsourcing

Sick Patients Need Cutting-Edge Drugs

This article brings up a good point, when a patient has no other choices and the potential of a new drug could offer some relief, what is the verdict at this point? The FDA has turned it's way of thinking around now to being much more conservative...

Published Sun, Aug 08 2008 2:29 AM by The Medical Quack

Filed under: Medically Related, Pharma/FDA News, drugs, Cancer, FDA, Pharmaceuticals

Johnson & Johnson Gets Rejected - Doribax

Well back to the drawing board to gather up some additional data. We live in a world of data today, overloaded data for that matter, and decisions just are not as simple as they used to be. With all the additional side effects coming to light...

Published Fri, Aug 08 2008 12:39 AM by The Medical Quack

Filed under: Medically Related, Pharma/FDA News, drugs, Pharma, FDA, Johnson and Johnson

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