FDA Announces 1998 Oversight Committee Meetings for Product, Establishment, and Biologics License Applications

Summary

The Food and Drug Administration (FDA) is conducting a review of its refusal to file (RTF) practices on product license applications (PLA's), establishment license applications (ELA's), and biologics license applications (BLA's) following the 1998 meetings of its standing oversight committee in the Center for Biologics Evaluation and Research (CBER).