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FiercePharma
19h
FDA warning letter reveals quality control, data integrity issues at Viatris plant in India
In a warning letter posted online late last month, the FDA scolded Viatris over a range of production slights at the ...
FiercePharma
20h
FDA looks to clarify confirmatory trial mandate for accelerated approvals
In recent years, the FDA has amped up its supervision of accelerated approvals, including by requiring that confirmatory ...
MassDevice
22h
Integra Lifesciences receives FDA warning letter for quality systems issues at three locations
Integra Lifesciences recently received an FDA warning letter pertaining to quality systems issues at several facilities.
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