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Tuesday, January 10, 2012 4:15 PM
“FDA is Slowing Growth”

Eight out of 10 California’s biomedical CEOs feel that cumbersome FDA processes is one of the biggest threats to growth. 

Biomedical CEOs in California continue to see a burdensome FDA regulatory environment as a major hindrance to the industry's growth, according to preliminary results of a  survey conducted by the California Healthcare Institute, BayBio and PwC.

In a preview of a broader survey to be released in February, 8 in 10 CEOs said that the current FDA regulatory approval process "has slowed the growth of their organization" and is among one of the biggest threats to the growth of the med-tech sector in the U.S. The preliminary results were released at the JP Morgan Healthcare conference in San Francisco. 

The United States' leadership position in the biomedical world was in jeopardy due to the cumbersome FDA process and that within five years, felt the CEOs, and "another country could conceivably recreate the ecosystem that has made the U.S. the leading biomedical region in the world," a prepared release described.

Other findings from the annual survey, which represents the largest biomedical market in the United States, include: 
  • 74 percent of respondents said their companies have had to delay research & development projects over the past year, with 40 percent blaming a lack of funding for the delays; 
  • 30 percent said they would seek corporate venture capital for funding, a three-fold increase from the previous year; and 
  • 60 percent said tax incentives for innovation was the most important public policy on a state level, while 51 percent pointed to tax reforms. 

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Thursday, January 12, 2012 by
That the product is safe and it is effective - sure sounds burdensome ...

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