FDA Announces Remaining 1997 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 (PLAs), establishment license applications (ELAs), and biologics license applications (BLAs) and will meet to discuss the results of this review, which will assess consistency across its offices and divisions in RTF decisions.