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Best of MedCitizens: A new path for biotech generics

Every week, MedCity News highlights the best of its MedCitizens: syndication partners and MedCity News readers who discuss life science current events on MedCityNews.com. Now here's the best of what YOU had to say: a proposal for a new approach on biogenerics, comparing Europe and U.S. medical device approvals, the danger of government involvement in electronic health records and the latest Boston Scientific-Guidant lawsuit.

Every week, MedCity News highlights the best of its MedCitizens: syndication partners and MedCity News readers who discuss life science current events on MedCityNews.com.

Now here’s the best of what YOU had to say:

Biotech companies, government need to forge a new concept of biogenerics. “Legislators seem to expect that the biotech market will follow the path trailblazed by the small molecule products. Those expectations, however, are badly misplaced. Here’s why.”

Does Europe offer faster, better approach than FDA on medical devices? “The medical device industry is touting a study it says debunks the Food & Drug Administration’s claims that there’s a safety benefit from the slower, more rigorous regulatory process in the U.S.”

New federal medical technology rules aren’t a ‘HIT.’ “New technologies can streamline the healthcare process and dramatically improve patient care. But if the government attaches burdensome rules and regulations to these tools, patient care could actually get worse.”

EHR certification process: A step-by-step breakdown. “NIST did a great job creating test scripts rapidly enough to enable vendors and hospitals to certify systems in time for meaningful use attestation. However, there are a few oddities in the scripts that are only discoverable during pilots in real hospital and eligible provider clinical settings. I strongly recommend that for all future certification, NIST pilot their scripts before they are issued for general use.”

BSX: Federal Guidant lawsuit ‘should not have a significant financial impact.’ “Boston Scientific Corp. said it’s disappointed with federal prosecutors over a civil lawsuit filed by the U.S. Justice Dept. over its white elephant Guidant Corp. acquisition, but downplayed the suit’s ultimate financial impact.”