FDAnews Drug Daily Bulletin

FDA WITHDRAWS TWO BLOOD-PRODUCT GUIDANCES

April 19, 2006
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The FDA is withdrawing two guidances on licensing blood products due to "a lack of industry interest" in pursuing either of the pilot programs, the agency said.

"Guidance for Industry: Gamma Irradiation of Blood and Blood Components: A Pilot Program for Licensing," was issued March 15, 2000. "Guidance for Industry: CBER Pilot Licensing Program for Immunization of Source Plasma Donors Using Immunogen Red Blood Cells Obtained from an Outside Supplier," was issued July 1, 2001.

Both guidances describe pilot programs "in which biologics manufacturers could self-certify conformance to licensing criteria prescribed by FDA," the notice states. The guidances were "intended to reduce unnecessary burdens for industry without diminishing public health protection."