Search:
 
This image is of a spacer graphic
NHF Face Book NHF Twitter
+ Login to my NHF
+ NHF Membership
+ Donate to NHF
+ Chapter Center
+ Hechos y Respuestas Rápidas
+ Ethics Advisory Committee
This image is of a spacer graphic
-Researchers and Healthcare Providers
 Research Grants Program
-Medical and Scientific Advisory Council
 Recent Recommendations
 What is MASAC?
 All MASAC Recommendations
 MASAC Members
 Nursing Working Group
 Social Work Working Group
 Physical Therapy Working Group
 Comprehensive Medical Care - Hemophilia Treatment Centers
 Cell Based Coagulation Animation
 Rare Bleeding and Clotting Disorders Resource Room
 The Partners in Bleeding Disorders Education Program
 NHF/Novo Nordisk HANDI Library

 

 

 
MASAC Document #145- MASAC RECOMMENDATION ON FUNDING OF THE OFFICE OF CELLULAR A
 

MASAC Document #145

MASAC RECOMMENDATION ON FUNDING OF THE OFFICE OF CELLULAR AND GENE THERAPIES

The following recommendation was approved by the Medical and Scientific Advisory Council (MASAC) of the National Hemophilia Foundation on June 7, 2003, and adopted by the NHF Board of Directors on October 19, 2003

View Printer-Friendly PDF Version >>.

Whereas the Office of Cellular and Gene Therapies (OCGT) of the FDA is responsible for regulatory oversight of therapies which may cure bleeding disorders;

Whereas the OCGT, a part of the Center for Biologics Evaluation and Review (CBER), has undergone significant reorganization as projects and resources have been shifted to the Center for Drug Evaluation and Review (CDER);

Whereas sufficient expertise and human resources are essential to safely move emerging technologies to potentially cure bleeding disorders into human clinical testing;

Therefore, the Medical and Scientific Advisory Council (MASAC) of the National Hemophilia Foundation recommends that sufficient resources be allotted to OCGT to allow for

1. A collaborative relationship to accelerate the development of innovative clinical studies, and
2. Rapid review of translational research from academic institutions and industry.