This article was originally published in RAJ Devices
GHTF releases updated version of IVD conformity assessment guidance
You may also be interested in...
US government to own doses of Regeneron's investigational cocktail antibody REGN-COV2 manufactured under a $450m contract and 100 million doses of Novavax's investigational vaccine under a $1.6bn agreement.
FDA approval for Perrigo's ANDA for two loperamide products listed as tablets follows CBE label changes Johnson & Johnson and BionPharma made for their branded OTCs containing the ingredient in 2019.
US OTC Decisions In June: Third Tentative Approval For Omeprazole Delayed Release ANDA, More Esomeprazole PPI Final Approvals
FDA told P&L Development, as it had with Aurobindo Pharma and Hetero Drugs, that its ANDA for a generic of Prilosec OTC delayed release is tentatively approved because exclusivity has not expired for Perrigo's first-approved generic of the PPI.