FDA weighs post-pandemic challenges at BIO meeting
Pharmaceutical companies and officials at the FDA are working with unprecedented speed and creativity during the coronavirus pandemic. But there’s little reason to think the workload will abate, or the problems become easier, in the post-pandemic lives of sponsors and regulators, according to panelists who spoke during an FDA Town Hall at the Digital BIO 2020 meeting.
Even amid the pandemic, not all of FDA’s work is centered on Covid-19 vaccines and treatments. “Let’s talk about PDUFA [the Prescription Drug User Fee Act],” said Richard Pops, chairman and CEO of Alkermes, Inc., who moderated the town hall. “First, looking backwards, we have a series of PDUFA goals that you are statutorily obliged to try to meet. How does that look outside of the antiviral and vaccine and Covid-related things?” he asked.
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