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The FDA Office of Digital Transformation posts its new IT operating plan and its 2023 annual report.[ Price : $8.95]
FDA approves an Ipsen Biopharmaceuticals NDA for Onivyde (irinotecan liposome) for use in combination with oxaliplatin, fluorourac...[ Price : $8.95]
Federal Register notice: FDA issues an order debarring Ross Lucien for five years from importing any drug into the U.S.[ Price : $8.95]
Federal Register notice: FDA issues an order to permanently debar Kalpen D. Patel from providing services in any capacity to a per...[ Price : $8.95]
Federal Register notice: FDA releases a draft guidance entitled Use of Data Monitoring Committees in Clinical Trials.[ Price : $8.95]
FDA warns Miami, FL-based US Chem Labs and Bronx, NY-based Helix Chemical that they are selling unapproved and misbranded versions...[ Price : $8.95]
FDA publishes an ICH draft guideline on post-approval safety data that is available for comment.[ Price : $8.95]
FDA clears a Nanox AI 510(k) for HealthFLD, an artificial intelligence software that provides automated qualitative and quantitati...