Protocols reviewed indicated a general increase in the content of Antigen E or Amb a I in Short Ragweed Extracts during the past year. Approximately 25 product lots were submitted for review. Potency levels of mite extracts appeared to be comparable to previous years, with approximately 70 lots of the two mite species submitted for review. Four manufacturers submitting lots of standardized cat for release maintained required potency levels. CBER did not fail to reproduce manufacturer's values for any submitted lots tested.

Agency
National Institute of Health (NIH)
Institute
Food and Drug Administration (FDA)
Type
Intramural Research (Z01)
Project #
1Z01BA001001-10
Application #
3804571
Study Section
Project Start
Project End
Budget Start
Budget End
Support Year
10
Fiscal Year
1991
Total Cost
Indirect Cost