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Diane Publishing Books
Drug Shortages: Certain Factors Are Strongly Associated with This Persistent Public Health Challenge
Marcia Crosse (au)
Drug shortages are a serious public health concern. Previous reports found that many shortages were of sterile injectable drugs and could generally be traced to supply disruptions caused by manufacturers slowing or halting production to address quality issues. This report reviewed several aspects of drug shortages. It examines: (1) trends in drug shortages; (2) the Food and Drug Administrationńˇ╗s (FDAńˇ╗s) efforts to prioritize reviews of drug submissions to address shortages; (3) trends in FDA warning letters issued to sterile injectable manufacturing establishments for noncompliance with manufacturing standards; and (4) the relationship between certain factors and shortages of sterile injectable drugs. Tables and figures. This is a print on demand report.
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