IoM Pediatric Report Calls For Congressional Action, Better Collaboration
This article was originally published in The Pink Sheet Daily
Institute says independent safety board may not be appropriate for devices, but experiences learned from the drug safety board may apply.
You may also be interested in...
The Institute’s Board on Health Sciences Policy is preparing a clinical trials registry for fall release.
The document, intended for industry reps, consumer associations and other stakeholders, explains how to secure a time slot for public portions of FDA meetings and “encourages” disclosure of financial relationships. The draft guidance is released shortly before the advisory committee on the safety of COX-2 inhibitors.
Although drug companies can be reluctant to partner with device firms on combo products, it is not FDA’s role to coerce firms to partner on cross-labeling development, participants at a Regulatory Affairs Professionals Society summit say. FDA will hold a meeting on cross-labeling in the spring.