lab

Combination Products: Post-marketing safety reporting

Understanding the expectations and challenges The pharmaceutical and medical device industries are seeing a substantial increase in combination products, and the related regulatory environment has been very dynamic. Recently, I was privileged to moderate a PharmaVOICE webinar on the latest U.S. FDA post-marketing safety reporting (PMSR) ruling and guidance. Expert …

COVID

Business continuity: how robust is your patient support disaster relief plan?

Weathering natural disasters and the COVID-19 pandemic To drive speed to therapy, reduce financial burdens and empower patient engagement, a Patient Support Services Call Center provides myriad support services that stakeholders depend upon. For pharmaceutical manufacturers, these services have gone from “nice to have” to “must-have,” driven by the growth …