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FDA warns New Hope Center for Reproductive Medicine and Regenerative Labs about violations involving human cells, tissue, and cell...[ Price : $8.95]
Three Goodwin attorneys analyze the results of BIMO inspections in 2022 and the beginning of 2023, listing most common violations....[ Price : $8.95]
Federal Register notice: FDA asks that consumer organizations notify the agency if they are interested in participating in selecti...[ Price : $8.95]
Federal Register notice: FDA makes available a revised draft guidance entitled Inborn Errors of Metabolism That Use Dietary Manage...[ Price : $8.95]
FDA accepts a BeiGene supplemental NDA for Brukinsa (zanubrutinib) in combination with obinutuzumab for treating adult patients wi...[ Price : $8.95]
CDER Office of Generic Drugs associate director of stakeholder and global engagement Sarah Ibrahim uses an agency podcast to urge ...[ Price : $8.95]
Federal Register notice: FDA announces a 9/11-12 Nonprescription Drugs Advisory Committee meeting to discuss decongestant phenylep...[ Price : $8.95]
ADC Therapeutics pauses new patient enrollment in the Phase 2 LOTIS-9 clinical trial evaluating Zynlonta (loncastuximab tesirine-l...