The
FDA has issued a new document:
“Guidance
for Industry: Recommendations for Screening, Testing, and Management of Blood
Donors and Blood and Blood Components Based on Screening Tests for Syphilis”
The
guidance is intended for blood establishments that collect Whole Blood or blood
components, including Source Plasma. The guidance announced in this notice
finalizes the draft guidance of the same title, dated March 2013 (2013 draft
guidance), and supersedes the memorandum of December 12, 1991, entitled “Clarification
of FDA Recommendations for Donor Deferral and Product Distribution Based on the
Results of Syphilis Testing.”
Posted by Tim Sandle
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