Ensuring that drugs used together as part of a treatment regimen are similarly labeled for combination therapy may require a new regulatory framework in the US or even legislation to streamline the process and overcome hurdles to cross-labeling, stakeholders suggested at the recent Friends of Cancer Research (FOCR) annual meeting.
Cross-labeling of products owned by different sponsors is always easier if the companies work together, and FDA should take measures within its existing authorities to encourage such collaboration, said Marc...