FDA Consolidates Drug Reviews

November 1, 2002
Oncology NEWS International, Oncology NEWS International Vol 11 No 11, Volume 11, Issue 11

ROCKVILLE, Maryland-The Food and Drug Administration (FDA) will consolidate the review of all new pharmaceutical products in its Center for Drug Evaluation and Research (CDER) by transferring the drug review duties currently handled by the Center for Biologics Evaluation and Research to CDER. Some reviews of biologics had gone to CDER previously, including those intended for use as oncologic drugs.

ROCKVILLE, Maryland—The Food and Drug Administration (FDA) will consolidate the review of all new pharmaceutical products in its Center for Drug Evaluation and Research (CDER) by transferring the drug review duties currently handled by the Center for Biologics Evaluation and Research to CDER. Some reviews of biologics had gone to CDER previously, including those intended for use as oncologic drugs.

A working group led by senior associate commissioner Murray M. Lumpkin, MD, will develop a plan by January 2003 for implementing the transfer.