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Life Sciences
Obama Veto Threat Looms Over Medical Device Tax Battle
Michael Causey, Editor-in-Chief,Association of Clinical Research Professionals With medical industry trade groups and [...]
FDA’s UDI Initiative Continues to Roll Forward
Jeff Mazik, Vice President, Life Science Solutions, AssurX With the close of the 7th Annual UDI Conference in Baltimor [...]
Will New User Fees Fuel More FDA Inspections?
For FY 2016, FDA is requesting $4.9 billion to support our essential functions and priority needs, which is $425 million [...]
FDA Warning Letters Hit Device Makers Over CAPA, MDR Failures
It’s been a little while since we checked the FDA’s outgoing mail tray to find out what inspectors are looking for – and [...]
Medical Device Makers Express Optimism About Future – But QA Worries About US Regulatory Burden
Crystal may be clear, but crystal balls, at least metaphorically, are certainly not. The late, great political columnist [...]
FDA 510(k) Approval Process Now Averages Over Six Months
If you’ve got six months – and nerves of steel – here’s some good news: You have a 61% percent chance of getting your m [...]
