FDA, Industry Group Seek Input on How to Prevent Drug Shortages
This article was originally published in The Gold Sheet
FDA requests comment on quality metrics, BARDA and other ideas for resolving and preventing drug shortages, while ISPE conducts industry survey on root causes and strategies for addressing the shortages.
You may also be interested in...
Move was meant to preempt others’ efforts to secure the next six months of Regeneron’s COVID-19 antibody therapeutic.
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.