Zdrowie i gospodarka · 22/06/2010

Guidance for Industry on Lupus Nephritis Caused By Systemic Lupus Erythematosus-Developing Medical Products for Treatment; Availability

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Lupus Nephritis Caused By Systemic Lupus Erythematosus--Developing Medical Products for Treatment." This guidance provides recommendations for industry on developing human drugs, therapeutic biological products, and medical devices for the treatment of lupus nephritis (LN) caused by systemic lupus erythematosus (SLE). This guidance finalizes the parts of the draft guidance entitled "Systemic Lupus Erythematosus--Developing Drugs for Treatment" (the draft guidance) regarding LN. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance entitled "Systemic Lupus Erythematosus--Developing Medical Products for Treatment," which finalizes the draft guidance. Additional organ-specific guidances will be developed in the future.