title: Re-processing of biological products: regulatory considerations from the CBER perspective.
authors: Division of Therapeutic Proteins, CBER, FDA, Rockville, Maryland 20852, USA. shacter@cber.fda.gov
authors: E
authors: E
authors: Shacter
mesh_terms: D001688:Biological Products; D001709:Biotechnology / Q000379:methods / Q000592:standards*; D033161:Government Regulation; D011786:Quality Control; D015203:Reproducibility of Results; D013678:Technology, Pharmaceutical / Q000379:methods / Q000592:standards*
chemical_list: D001688:Biological Products