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masterlongevity

01/02/12 6:51 PM

#134166 RE: DewDiligence #134162

" The FDA will shift from being a gold standard to a late adopter as companies will focus on getting to markets outside of the United States first because of the complexity and challenge at the FDA. [Comments?] "

I highly doubt this, at least in the near future. The FDA is by far the easiest agency to work with and the fastest for drug approvals. The EMEA is slower and the reimbursement situation in the EU makes getting profit slower. Other regions are even more difficult (e.g japan PMDA).
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jq1234

01/02/12 9:28 PM

#134172 RE: DewDiligence #134162

Regulatory barriers will increase in the United States and lead companies to look to emerging markets for first approvals of new products. [This has very rarely happened in the past for diseases that were not specific to the emerging-market countries in question.]



The FDA will shift from being a gold standard to a late adopter as companies will focus on getting to markets outside of the United States first because of the complexity and challenge at the FDA. [Comments?]



I read the article more than a week ago. I would have posted here if I weren't strongly disagreeing with these two points - I did retweeted it though. It takes much longer to get drugs approved in emerging markets in general. As of FDA becoming late adopter, companies seeking approvals outside of US first, maybe this is true for CE Mark (device), but for drugs, companies still seek approval in US first.


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genisi

01/10/12 5:24 AM

#134707 RE: DewDiligence #134162

In 2011, the long-awaited $1,000 genome will arrive

It's here and the winner is LIFE:

Life Technologies Introduces the Benchtop Ion Proton™ Sequencer; Designed to Decode a Human Genome in One Day for $1,000

http://finance.yahoo.com/news/Life-Technologies-Introduces-prnews-2249074943.html?x=0