FDA CONSOLIDATES DRUG REVIEW

Abstract

FDA HAS ANNOUNCED THAT it will shift the review of biotechnology drugs from its biologics division to its main drug division, the Center for Drug Evaluation & Research (CDER). Currently, CDER oversees traditional pharmaceuticals made using chemical processes. The purpose of the consolidation is to shorten review times for new biologics—drugs derived from living organisms—and to make the review of biologics and traditional chemical drugs consistent. By carefully combining part of our present biologics review operations responsibilities with our drug review operation, FDA will be optimally positioned to uphold its reputation for high-quality evaluations, says FDA Deputy Commissioner Lester M. Crawford. The Biotechnology Industry Organization praises FDA's decision. We are pleased with the Bush Administration's efforts to bring lifesaving drugs to patients faster alongside greater consistency in the drug development and review process, BIO President Carl B. Feldbaum says. One catalyst for this consolidat...