Why Should We Rescue The Legislative Intent Of The BPCIA?
By Peter J. Pitts, Robert Popovian, and Wayne Winegarden
What happens when regulatory ambiguity displaces sound scientific guidance, deterring the legislative intent of Congress? This is precisely the situation regarding the FDA changing the regulatory rules of the road regarding a biosimilar’s strength versus its potency. It is a distinction with a difference – with the potential unintended consequence of disincentivizing both the development and uptake of biosimilars. It is also important to consider the implications of the legislative intent of the Biologics Price Competition and Innovation Act of 2009 (BPCIA) and how it can be improved.
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World s Best Smart Hospitals 2021 By Newsweek
World s Best Smart Hospitals 2021
The pandemic put hospitals through the ultimate stress test. By forcing them to adapt to waves of COVID-19 patients, changing treatment protocols, faltering supply chains and a massive vaccine rollout, to name just a few of the challenges of the past year, the outbreak drove home the importance of advanced technology. The hospitals that best weathered the crisis were by and large the ones that were already open to integrating new technologies and taking advantage of data-driven opportunities as they become available. This lesson may turn out to be one of the most profound and lasting effects of the pandemic. Hospitals around the world now have a renewed sense of urgency to provide effective telehealth services, use real-time data to quickly and efficiently allocate staff and other resources where most needed and monitor the flow of patients along care pathways during peak demand periods.