Obama Veto Threat Looms Over Medical Device Tax Battle
Michael Causey, Editor-in-Chief,Association of Clinical Research Professionals [...]
23
07, 2015
20
07, 2015
FDA’s UDI Initiative Continues to Roll Forward
Jeff Mazik, Vice President, Life Science Solutions, AssurX With the close of t [...]
15
07, 2015
Will New User Fees Fuel More FDA Inspections?
For FY 2016, FDA is requesting $4.9 billion to support our essential functions a [...]
14
07, 2015
FDA Warning Letters Hit Device Makers Over CAPA, MDR Failures
Michael Causey, Editor-in-Chief,Association of Clinical Research Professionals [...]
30
06, 2015
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 [...]
23
06, 2015
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 [...]
19
06, 2015
FDA Issues Deadline Reminder to Medical Device Companies on Electronic Medical Device Reporting
Tamar June, VP, Strategic Marketing, AssurX, Inc. Looks like it's crunch time [...]
10
06, 2015
FDA Moves UDI Initiative Further Down the Production Line
We, and others, like to take the FDA to task for missing deadlines or behaving i [...]
4
06, 2015
Large Utilities Power Up with AssurX Enterprise GRC Solution
Increasingly complicated, and disparate, regulatory requirements and a demand fo [...]
20
05, 2015
Congress Crawls Out of 20th Century to Push Bi-partisan ‘Cures’ Legislation
Michael Causey, Editor & Publisher, eDataIntegrityReport.com Just when we' [...]
