Daily Archives: April 14, 2016


Summary: Navigating Regulatory Expectations: Lessons Learned for Advertising and Promotion

In summary, I presented seven relevant cases and some key learnings for promotional guidance. In a new class, the mechanism of action needs to be pulled through to show that it actually made a difference in the clinical trial results. In the pharmacokinetics, we saw that a difference on label of PK performance could have promotionally relevant and competitively viable differences in dosing. In drug delivery and release, we saw that the profile of the therapeutic window could be promotional, allowed, if it were also shown to be patient-relevant in either efficacy or side effects. When we looked at dermatological […]