Resource Type

Anthrax Vaccine: Changes to the Manufacturing Process (open access)

Anthrax Vaccine: Changes to the Manufacturing Process

Testimony issued by the General Accounting Office with an abstract that begins "The original anthrax vaccine was developed in the 1950s and was first produced on a large scale by Merck. The BioPort Corporation in Michigan is now the sole facility in the United States capable of producing the vaccine. The Food and Drug Administration (FDA) licenses biological products and their production facilities. The manufacturer is required to comply with current good manufacturing practices, which regulate personnel, buildings, equipment, production controls, records, and other aspects of the vaccine manufacturing process. When there is a major change in the manufacturing process, the manufacturer must submit evidence to FDA showing that the change does not have any adverse effects. The manufacturer must also ensure that the quality of the product is maintained. In the case of the anthrax vaccine, the Michigan facility did not notify FDA of several changes to the manufacturing process in the early 1990s, and no specific studies were done to confirm that vaccine quality was not affected. FDA inspections found several deficiencies, many of which were not corrected in a timely manner."
Date: October 23, 2001
Creator: United States. General Accounting Office.
Object Type: Text
System: The UNT Digital Library
Women in Management: Analysis of Selected Data From the Current Population Survey (open access)

Women in Management: Analysis of Selected Data From the Current Population Survey

A letter report issued by the General Accounting Office with an abstract that begins "GAO analyzed data from the Department of Labor's Current Population Survey (CPS) to better understand the challenges that women face in advancing their careers. Female managers in most of the industries GAO examined had less education, were younger, were more likely to work part-time, and were less likely to be married than were male managers. There was no statistically significant difference between the percent of management positions filled by women and the percent of all positions filled by women for five of the 10 industries GAO examined. In addition, in 1995 and 2000, full-time female managers earned less than full-time male managers, after controlling for education, age, marital status and race."
Date: October 23, 2001
Creator: United States. General Accounting Office.
Object Type: Report
System: The UNT Digital Library