HCT/Ps Resources - Comments 

Comments

Comments: Questions From Cord Blood Licensure Workshop Submitted to FDA Docket – 4/8/10
Comments to FDA for Draft IND Guidance on HPC-Cs – 1/14/10

Archived Comments

2009

Comments to FDA on cGTP and Additional Requirements for Manufacturers of HCT/Ps – 4/14/09

2008

Comments to FDA on Draft Guidance on Considerations for Pancreatic Islet Cell Products – 8/8/08
Comments to FDA on Draft Guidance for Validation of RMM for Sterility Testing of Cellular and Gene Therapy Products – 5/9/08

2007

Comments to FDA on Draft Guidance for Cell Selection Devices - 9/19/07
Comments on Draft Guidance for Cord Blood Licensure - 4/16/07
Comments to FDA on Proposed National Drug Code Requirements for HCT/Ps – 1/24/07 (PDF)

2004

Comments to FDA on Draft Guidance for HCT/P Donor Eligibility Determination – 8/23/04