2005D-0330 Guidance for Industry and FDA Review Staff on Collection of Platelets by Automated Methods
FDA Comment Number : EC1
Submitter : Mr. Robert Currie Date & Time: 12/05/2005 05:12:35
Organization : Scott
Category : Health Care Association
Issue Areas/Comments
GENERAL
GENERAL
We collect double units from many of our donors. We are concerned that the proposed limitation of 24 products per annum would cause a serious shortage of platelets. We would rather that the current industry standard be followed and donors be allowed to donate 24 times per annum. There is no evidence to indicate that this is a risk to the donor.