TY - GEN AU - Edwards,Beatrice J AU - Gounder,Mrinal AU - McKoy,June M AU - Boyd,Ian AU - Farrugia,Mathew AU - Migliorati,Cesar AU - Marx,Robert AU - Ruggiero,Salvatore AU - Dimopoulos,Meletios AU - Raisch,Dennis W AU - Singhal,Seema AU - Carson,Ken AU - Obadina,Eniola AU - Trifilio,Steve AU - West,Dennis AU - Mehta,Jayesh AU - Bennett,Charles L TI - Pharmacovigilance and reporting oversight in US FDA fast-track process: bisphosphonates and osteonecrosis of the jaw SN - 1474-5488 PY - 2008///1210 KW - Administration, Oral KW - Adverse Drug Reaction Reporting Systems KW - Antineoplastic Agents KW - administration & dosage KW - Bone Density Conservation Agents KW - adverse effects KW - Diphosphonates KW - Drug Approval KW - Female KW - Humans KW - Imidazoles KW - Incidence KW - Infusions, Intravenous KW - Jaw KW - drug effects KW - Male KW - Osteonecrosis KW - chemically induced KW - Pamidronate KW - Precipitating Factors KW - Tooth Extraction KW - United States KW - epidemiology KW - United States Food and Drug Administration KW - Zoledronic Acid N1 - Publication Type: Journal Article; Research Support, N.I.H., Extramural; Review UR - https://doi.org/10.1016/S1470-2045(08)70305-X ER -