Good Review Practices IND guidance ready for dissemination within FDA -- CBER's Schwieterman.

Executive Summary

IND GOOD REVIEW PRACTICES DRAFT GUIDANCE READY FOR DISSEMINATION WITHIN FDA, Center for Biologics Evaluation & Research Immunology & Infectious Disease Branch Chief William Schwieterman, MD, a member of the guidance committee, told the University of Texas' International Industrial Pharmacy conference in Austin on Feb. 26. The IND GRP document "should come out this year," Center for Drug Evaluation & Research Director Janet Woodcock, MD, predicted at the IIPC meeting. Schwieterman noted that FDA will eventually seek industry input into the document.