Codevelopment Of A New Medical Entity And Companion Diagnostic

If the label of a new medicine is to include the obligatory use of a test, the manufacturer needs to take care that drug and test are developed in tandem and receive regulatory approval in such a fashion that they can reach the market simultaneously. Authorities are paying increasing attention to the challenges that this process may present. The U.S. Food and Drug Administration has issued a concept paper on "Drug-Diagnostic Co-development" (http://www.fda.gov/Cder/genomics/pharmacoconceptfn.pdf) that specifically addresses this issue. A number of working groups, including the International Conference on Harmonization, are also currently addressing aspects related to this issue, from coining unified terminology and language around biomarkers and companion diagnostics, to formal issues relating to regulatory submissions and the evidentiary standards that will be required to accept a companion diagnostic as valid and useful.

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.

Get My Free Ebook


Post a comment