Summary

One of multiple important parts of the critical path initiative at the FDA has been a growing interest and attention to the issue of biomarkers, particularly with regard to the role they play as tools to aid in development of drugs and other new therapies. The FDA appreciates that the coordination of reviews across these two product lines may be challenging and has both administrative and regulatory tools in place that can contribute to review successes for these products. Scientific models for optimal evaluation are currently a matter of great interest and discussion at the FDA, and scientists in all three centers regulating human products (CDER, CBER, and CDRH) have had multiple interactions with stakeholders and sponsors of new technologies. It is our belief that the FDA is well positioned to help foster the use of this new technology. We believe that the challenge at hand is taming the science itself and that the FDA can in a nimble manner review new products, assure they are safe and effective, and bring them to market in a manner consistent with the precepts of the critical path program.

Project Management Made Easy

Project Management Made Easy

What you need to know about… Project Management Made Easy! Project management consists of more than just a large building project and can encompass small projects as well. No matter what the size of your project, you need to have some sort of project management. How you manage your project has everything to do with its outcome.

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