This PDF is the current document as it appeared on Public Inspection on 06/26/2012 at 08:45 am.
The Food and Drug Administration (FDA) is announcing the withdrawal of a guidance published in the Federal Register of June 22, 2010.
June 27, 2012.
FOR FURTHER INFORMATION CONTACT:
Leila P. Hann, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave. Bldg. 22, rm. 3143, Silver Spring, MD 20993-0002, 301-796-3367;
Philip Desjardins, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave. Bldg. 66, rm. 5437, Silver Spring, MD 20993-0002, 301-796-5678;
Stephen Ripley, Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448, 301-827-6210.
In a notice published in the Federal Register of June 22, 2010 (75 FR 35492), FDA announced the availability of a guidance entitled “Lupus Nephritis Caused By Systemic Lupus Erythematosus—Developing Medical Products for Treatment.” This guidance is being withdrawn because it does not reflect FDA's current thinking on the development of medical products for the treatment of lupus nephritis.
Dated: June 22, 2012.
Assistant Commissioner for Policy.
[FR Doc. 2012-15716 Filed 6-26-12; 8:45 am]
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