Biotech Values

[jq1234]

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.