FDA Consolidates Drug Reviews

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Oncology NEWS InternationalOncology 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.

Articles in this issue
Zoledronic Acid Reduces SREs in Solid Tumors
Study Supports Wider Use of SLN Biopsy in Breast Cancer
Minorities Less Likely Than Whites to Receive Good Pain Care
Polyglutamate-Paclitaxel Controls Recurrent Ovarian Cancer
9cRA Shown to Reverse Premaliagnant Changes in Ex-Smokers
FDA Names New ODAC Chair
Neoadjuvant Weekly Paclitaxel Effective in Advanced Breast Cancer
Docetaxel Plus Gemcitabine Promising in Advanced Pancreatic Cancer
Polysaccharides Unique Targets for Immunotherapy
Genetic Fingerprinting Shows Distinct Sarcoma Subsets
Education on Increased ICP Reduces Nursing ‘Headache’
NCI Begins Trial of Spiral CT vs X-rays as a Screening Test
Good But Short-Lived Responses to Rituximab in LPHD
ODAC Supports Use of Iressa for Third-Line Therapy of NSCLC
Subcutaneous Alemtuzumab Produces High Complete Response Rate in Untreated CLL
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