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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.
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PS027181

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