Recipient: Robert Hostoffer D.O.-Allergy and Immunology Associates
Product: Investigational biologics product
Date: 6/6/05

You failed to collect the paper diary or electronic diary data as required by the protocol. The protocol stated that the paper diary was to be reviewed during the subject’s periodic visits with the clinical investigator (every 3-4 weeks) and that the electronic diary data were to be downloaded each night and available for the investigator’s review which will then be electronically transferred to the sponsor. Although the electronic diary for subject _____ was not functional from March through September 2003, there is no evidence that you collected the information about the safety of the study drug during this period.

Issuer: Center for Biologics Evaluation and Research (CBER)