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Federal Register notice: FDA makes available a revised draft guidance entitled Inborn Errors of Metabolism That Use Dietary Management: Considerations...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