ELA, LOT-RELEASE TO BE ELIMINATED FOR "WELL-CHARACTERIZED" BIOLOGICALS; ADVERTISING PRECLEARANCE NO LONGER REQUIRED BY CBER -- "REINVENTING GOVERNMENT" PLAN
Executive Summary
Biologics establishment license applications and lot-release requirements will be eliminated for "well-characterized" products as part of FDA's "Reinventing Government" initiative, Vice President Gore and FDA Commissioner Kessler announced at a White House press conference Nov. 9.