Coronavirus Notebook: US FDA's Paper Push, Industry Execs/US Officials Emphasize Their Collaboration
Dispatches from a world turned upside down include the US FDA expressing confidence in Chinese manufacturers – to make their GDUFA payments; projections of drug shortages for ventilator patients; and the launch of new hydroxychloroquine studies.
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Technology modernization efforts, the expansion of cloud-based submission capabilities, and the ongoing COVID-19 pandemic could serve as catalysts to broaden FDA’s Real-Time Oncology Review program beyond cancer therapeutics, Pfizer exec Richard Jahn says.
COVID-driven supply shortages were both the cause of and solution to production deficiencies for manufacturers of neuromuscular blocking agents; US FDA is permitting Mylan, Gland, and Fresenius Kabi to distribute vecuronium bromide and rocuronium bromide even though they do not have the ‘paralyzing agent’ warning on the caps since the products are in high demand at ICUs. The appropriately embossed caps were unavailable due to supply chain disruptions caused by the pandemic.
It is nice for pharma CEOs to be called ‘brilliant’ by a President who once said they are ‘getting away with murder.’ But the ‘new’ Trump rhetoric still has major pitfalls for industry – including a fundamental risk of undermining regulatory standards.