COVID-19 Contracting Accelerated As US Fiscal Year 2020 Drew To A Close
US government stockpiles more drugs, refines pandemic surveillance with wastewater sampling and more as it braces for winter.
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The US FDA shaved months from review of Gilead’s Veklury (remdesivir) for COVID-19 with post-approval commitments for multiple stability studies. The Pink Sheet takes a deep dive look at discussions within the agency and with the sponsor.
FDA historically has based 100% of drug adulteration warning letters on inspections but COVID-19-related travel restrictions began changing that in FY 2020, when 2% of drug GMP warning letters were based on testing import samples. The change became even more pronounced in the first two months of FY 2021, with 59% of actions related to sample testing and 41% to inspections.
Government offers help securing supplies in return for another 100 million doses by Q2. That would mean abandoning Pfizer’s preferred arms-length relationship.