Guidance for Industry on Lupus Nephritis Caused by Systemic Lupus Erythematosus-Developing Medical Products for Treatment; Withdrawal of Guidance

---
identifier: "/us/fr/2012-15716"
source: "fr"
legal_status: "authoritative_unofficial"
title: "Guidance for Industry on Lupus Nephritis Caused by Systemic Lupus Erythematosus-Developing Medical Products for Treatment; Withdrawal of Guidance"
title_number: 0
title_name: "Federal Register"
section_number: "2012-15716"
section_name: "Guidance for Industry on Lupus Nephritis Caused by Systemic Lupus Erythematosus-Developing Medical Products for Treatment; Withdrawal of Guidance"
positive_law: false
currency: "2012-06-27"
last_updated: "2012-06-27"
format_version: "1.1.0"
generator: "[email protected]"
agency: "Health and Human Services Department"
document_number: "2012-15716"
document_type: "notice"
publication_date: "2012-06-27"
agencies:
  - "Health and Human Services Department"
  - "Food and Drug Administration"
fr_citation: "77 FR 38305"
fr_volume: 77
docket_ids:
  - "Docket No. FDA-2010-D-0249"
fr_action: "Notice; withdrawal."
---


#  Guidance for Industry on Lupus Nephritis Caused by Systemic Lupus Erythematosus—Developing Medical Products for Treatment; Withdrawal of Guidance

**AGENCY:**

Food and Drug Administration, HHS.

**ACTION:**

Notice; withdrawal.

**SUMMARY:**

The Food and Drug Administration (FDA) is announcing the withdrawal of a guidance published in the *Federal Register* of June 22, 2010.

**DATES:**

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;

or

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;

or

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.

**SUPPLEMENTARY INFORMATION:**

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 This guidance is being withdrawn because it does not reflect FDA's current thinking on the development of medical products for the treatment of lupus nephritis.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.

Leslie Kux,

Assistant Commissioner for Policy.