Home »
Rulemaking » Draft Guidance for Industry:Recommedations for Donor Questioning, Deferral, Reentry, and Product Management to Reduce Risk of Transfusion-Transmitted Malaria; Availability
Draft Guidance for Industry:Recommedations for Donor Questioning, Deferral, Reentry, and Product Management to Reduce Risk of Transfusion-Transmitted Malaria; Availability
References 1, 2, 8, 10, 11, 13, you can go to the Food and Drug Administration web site for the refer material and you can to the Center for Disease Control and Prevention (CDC) for references 15, 16, 20, 21, 22 (mb) 8/9/2012
Document Subtype:
Notice of Data Availability
Received Date:
July 06 2012, at 12:00 AM Eastern Daylight Time
Start-End Page:
40068 - 40069
Page Count:
2
Comment Start Date:
July 6 2012, at 12:00 AM Eastern Standard Time
Comment Due Date:
September 4 2012, at 11:59 PM Eastern Standard Time
Attachments:
List - Malaria references
View Attachment:
Title: List - Malaria references
Reference 12 Spencer B et al Risk for malaria in United States donors deferred for travel to malaria endemic areas
View Attachment:
Title: Reference 12 Spencer B et al Risk for malaria in United States donors deferred for travel to malaria endemic areas
Reference 14 FDA Blood Products Advisory Committee Bebefit Risk Analysis for Malaria Exposure in Blood Donors from Mexico and Its Effect on Blood Safety and Avilability Mark Walderhaug November 16 2009
View Attachment:
Title: Reference 14 FDA Blood Products Advisory Committee Bebefit Risk Analysis for Malaria Exposure in Blood Donors from Mexico and Its Effect on Blood Safety and Avilability Mark Walderhaug November 16 2009
Reference 17 Vinetz J M et al Plasnodium malaria infection in an asymptomatic 74 years old Greek woman with splenomegaly
View Attachment:
Title: Reference 17 Vinetz J M et al Plasnodium malaria infection in an asymptomatic 74 years old Greek woman with splenomegaly
Reference 18 Kitchen A et al Transfusion transmitted malaria current donor selection guidelines are not sufficient
View Attachment:
Title: Reference 18 Kitchen A et al Transfusion transmitted malaria current donor selection guidelines are not sufficient
Reference 19 Griffith K S et al Treatment of malaria in the United States a systematic review
View Attachment:
Title: Reference 19 Griffith K S et al Treatment of malaria in the United States a systematic review
Reference 23 Liljander A et al Influences of intermittent preventive treatment and persistent multiclonal Plasmodium falciparum infections on clinical malaria risk
View Attachment:
Title: Reference 23 Liljander A et al Influences of intermittent preventive treatment and persistent multiclonal Plasmodium falciparum infections on clinical malaria risk
Reference 24 Doolan D L et al Acquired immunity to malaria
View Attachment:
Title: Reference 24 Doolan D L et al Acquired immunity to malaria
Reference 3 - Westphal R Transfusion-transmitted malarial infections In Smith D and Dodd R eds Transfusion Transmitted Infections ASCP Press Chicago 1991
View Attachment:
Title: Reference 3 - Westphal R Transfusion-transmitted malarial infections In Smith D and Dodd R eds Transfusion Transmitted Infections ASCP Press Chicago 1991
Reference 4 Mungai M Tegtmeier G Chamberland M Parise M Transfusion transmitted malaria in the United States from 1963 through 1999 New England Journal of Medicinie
View Attachment:
Title: Reference 4 Mungai M Tegtmeier G Chamberland M Parise M Transfusion transmitted malaria in the United States from 1963 through 1999 New England Journal of Medicinie
Reference 5 Guerrero I C Weniger B C Schultz M G Transfusion malaria in the United States
View Attachment:
Title: Reference 5 Guerrero I C Weniger B C Schultz M G Transfusion malaria in the United States
Reference 6 Nahlen B L Lobel H O Cannon S E Campbell CC Reassessment of blood donor selection criteria for United States traveler to malarious areas
View Attachment:
Title: Reference 6 Nahlen B L Lobel H O Cannon S E Campbell CC Reassessment of blood donor selection criteria for United States traveler to malarious areas
Reference 7 Sazama K Prevention of transfusion tranmitted malaria Is it time to revisit the standards
View Attachment:
Title: Reference 7 Sazama K Prevention of transfusion tranmitted malaria Is it time to revisit the standards
Reference 9 Seed C R et al The efficacy of a malarial antibody enzyme immunoassay for establishing the reinstatement status of blood donors potentially exposed to malaria
View Attachment:
Title: Reference 9 Seed C R et al The efficacy of a malarial antibody enzyme immunoassay for establishing the reinstatement status of blood donors potentially exposed to malaria
Draft Guidance for Industry:Recommedations for Donor Questioning, Deferral, Reentry, and Product Management to Reduce Risk of Transfusion-Transmitted Malaria; Availability
Details Information
Attachments:
List - Malaria references
View Attachment:Reference 12 Spencer B et al Risk for malaria in United States donors deferred for travel to malaria endemic areas
View Attachment:Reference 14 FDA Blood Products Advisory Committee Bebefit Risk Analysis for Malaria Exposure in Blood Donors from Mexico and Its Effect on Blood Safety and Avilability Mark Walderhaug November 16 2009
View Attachment:Reference 17 Vinetz J M et al Plasnodium malaria infection in an asymptomatic 74 years old Greek woman with splenomegaly
View Attachment:Reference 18 Kitchen A et al Transfusion transmitted malaria current donor selection guidelines are not sufficient
View Attachment:Reference 19 Griffith K S et al Treatment of malaria in the United States a systematic review
View Attachment:Reference 23 Liljander A et al Influences of intermittent preventive treatment and persistent multiclonal Plasmodium falciparum infections on clinical malaria risk
View Attachment:Reference 24 Doolan D L et al Acquired immunity to malaria
View Attachment:Reference 3 - Westphal R Transfusion-transmitted malarial infections In Smith D and Dodd R eds Transfusion Transmitted Infections ASCP Press Chicago 1991
View Attachment:Reference 4 Mungai M Tegtmeier G Chamberland M Parise M Transfusion transmitted malaria in the United States from 1963 through 1999 New England Journal of Medicinie
View Attachment:Reference 5 Guerrero I C Weniger B C Schultz M G Transfusion malaria in the United States
View Attachment:Reference 6 Nahlen B L Lobel H O Cannon S E Campbell CC Reassessment of blood donor selection criteria for United States traveler to malarious areas
View Attachment:Reference 7 Sazama K Prevention of transfusion tranmitted malaria Is it time to revisit the standards
View Attachment:Reference 9 Seed C R et al The efficacy of a malarial antibody enzyme immunoassay for establishing the reinstatement status of blood donors potentially exposed to malaria
View Attachment:Comments
View AllPosted: 07/19/2012 ID: FDA-2000-D-0187-0004
Sep 04,2012 11:59 PM ET
Posted: 08/07/2012 ID: FDA-2000-D-0187-0007
Sep 04,2012 11:59 PM ET
Posted: 08/30/2012 ID: FDA-2000-D-0187-0008
Sep 04,2012 11:59 PM ET
Posted: 08/31/2012 ID: FDA-2000-D-0187-0009
Sep 04,2012 11:59 PM ET
Posted: 09/05/2012 ID: FDA-2000-D-0187-0013
Sep 04,2012 11:59 PM ET
Related Documents