Regulatory Focus™ > News Articles > Citing a Change in Thinking, FDA Withdraws Lupus Product Guidance

Citing a Change in Thinking, FDA Withdraws Lupus Product Guidance

Posted 26 June 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) said it is withdrawing a guidance document published in June 2010 in light of the document no longer reflecting its current thinking on the topic.

In its 26 June 2012 Federal Register posting, FDA said its guidance, "Lupus Nephritis Caused by Systemic Lupus Erythematosus-Developing Medical Products for Treatment," was being withdrawn immediately.

Systemic Lupus Erythamatosus is an autoimmune disease in which the body's immune system attacks cells and tissues within the body. This can cause a condition known as lupus nephritis, which is characterized by the inflammation of the kidney. FDA did not offer any explanation as to why it was withdrawing the guidance, and what could have changed between June 2010 and June 2012 to differently inform its thought process.

There are no public comments listed in the Regulations.gov web docket for the 2010 notice, implying FDA came to its decision by its own accord or through non-public comments.


Read more:

FDA - Guidance for Industry; Withdrawal: Lupus Nephritis Caused By Systemic Lupus Erythematosus--Developing Medical Products for Treatment


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