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FDA warns Seattle, WA-based Kari Gran, Inc., about CGMP violations and data integrity issues in its production of finished drugs.[ Price : $8.95]
As a sign FDA is continuing to raise the bar on data needed to gain approval for a PI3K inhibitor, MEI Pharma and Kyowa Kirin deci...[ Price : $8.95]
CDER researchers describe Covid-19 drug safety surveillance lessons learned.[ Price : $8.95]
Three former FDA Team Biologics inspectors tell Politico inspections are being conducted by team members who do not have sufficien...[ Price : $8.95]
Pfizer and BioNTech file an application seeking an emergency use authorization for their Omicron BA.4/BA.5-adapted bivalent Covid-...[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Statistical Approaches to Establishing Bioequivalence.[ Price : $8.95]
Novartis says it will seek FDA approval for an expanded use for Pluvicto (lutetium Lu 177 vipivotide tetraxetan), for slowing dise...[ Price : $8.95]
FDA posts a final guidance entitled E19 A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-Approval or Post...