FDA accepts for review a Dr. Reddys Laboratories BLA for its proposed biosimilar rituximab (Genentechs Rituxan) candidate.
CDER Office of Generic Drugs associate director of stakeholder and global engagement Sarah Ibrahim uses an agency podcast to urge companies to conside...
FDA warns Santa Rosa, CA-based NeilMed Pharmaceuticals about CGMP and other issues in its production of finished drugs.
VeganMed asks FDA to require drug and dietary supplement manufacturers to disclose in product labeling any animal-derived ingredients in their product...
FDA approves Boston Scientifics Vercis Neural Navigator 5 Software, which is used as part of the Vercise Genus Deep Brain Stimulation System for treat...
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...
