That the FDA has new guidelines for informal review processes for medical device applications?
FDA is urging increased modernization in clinical trials. Are you familiar with the essential elements of computerized systems used in clinical trials?
Especially for Pharmaceuticals
The forthcoming Supreme Court decision regarding the Riegel vs. Medtronic case will be a decision that marks the future path of medical device companies within the U.S.
Especially for Medical Devices
Meet a New Alligator, it’s the QA/IT Disconnect By Keith Parent
During the 1990s, a handful of Fortune 500 companies lost hundreds of millions trying to implement complex enterprise software systems. In some cases, projects dragged on for years before the companies killed them. Business executives were tearing their hair out trying to get a handle on the cost explosion and failed projects. How do you explain to shareholders and the board of directors that you spent two years and $500 million on world-changing information technology (IT) and yet have absolutely nothing to show for it? The business press rightfully called these disasters “corporate train wrecks.” CEOs lost their jobs. As did scores of Chief Information Officers (CIOs) who convinced the business execs to make these leaps of faith. CIOs sold these projects as “slam dunks.” They were anything but. Little wonder that the half-life of a CIO fell to 18 months or that his/her respective title became known as Career is Over.
Optimizing Your eCTD Submission: How to Achieve an Efficient and Timely Review
If you?re having problems submitting your eCTDs, you are not alone. Ginny Ventura, Regulatory Information Specialist in the Center for Drug Evaluation and Research frequently sees submissions with common errors. In a presentation to DIA, she outlined the top 12 issues for eCTD success:
12. SPL must be in an ?SPL? folder
11. Use elements and leaf titles correctly
- Not necessary to use every element in the eCTD Specification
- Use only the elements you need
- Placeholder documents are not necessary, and can divert reviewers? time and attention
- Leaf titles
- Should be informative and succinct
- Should not include the eCTD numbering
- Should immediately reveal to the reviewer what?s inside
10. Be sure to reference all files in the XML backbone(s). Unreferenced files result from missing or mislocated directory references in xlink:href, ?extra? files and from failing to repeat a complete directory structure on each media component in a set. Unreferenced files can?t be located by reviewers.