Draft Guidance for Industry: Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
(Source: What's New at CBER)
Source: What's New at CBER - June 9, 2014 Category: Biomedical Science Source Type: news
Draft Guidance for Industry: Use of Donor Screening Tests to Test Donors of Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps) for Infection with Treponema pallidum (Syphilis)
(Source: What's New at CBER)
Source: What's New at CBER - June 9, 2014 Category: Biomedical Science Source Type: news
Guidance for Industry and FDA Staff: IND Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients with Disorders Affecting the Hematopoietic System
(Source: What's New at CBER)
Source: What's New at CBER - June 5, 2014 Category: Biomedical Science Source Type: news
Guidance for Industry: BLA for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients with Disorders Affecting the Hematopoietic System
(Source: What's New at CBER)
Source: What's New at CBER - June 5, 2014 Category: Biomedical Science Source Type: news
Officer/ Employee List for STN 125478/0, RAGWITEK
(Source: What's New at CBER)
Source: What's New at CBER - May 9, 2014 Category: Biomedical Science Source Type: news
Summary Basis for Regulatory Action - ALPROLIX
(Source: What's New at CBER)
Source: What's New at CBER - April 16, 2014 Category: Biomedical Science Source Type: news
CBER FY 2013 Recall Posting
(Source: What's New at CBER)
Source: What's New at CBER - April 3, 2014 Category: Biomedical Science Source Type: news
Draft Guidance for Industry: Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies.
(Source: What's New at CBER)
Source: What's New at CBER - February 26, 2014 Category: Biomedical Science Source Type: news
Direct Recall Classification Program
CBER’s Direct Recall Classification (DRC) program provides establishments the opportunity to electronically report recall related information directly to CBER. (Source: What's New at CBER)
Source: What's New at CBER - February 24, 2014 Category: Biomedical Science Source Type: news
Guidance for Industry: Use of Nucleic Acid Tests on Pooled and Individual Samples from Donors of Whole Blood and Blood Components, Including Source Plasma, to Reduce the Risk of Transmission of Hepatitis B Virus
(Source: What's New at CBER)
Source: What's New at CBER - February 24, 2014 Category: Biomedical Science Source Type: news
Guidance for Industry: Pre-Storage Leukocyte Reduction of Whole Blood and Blood Components Intended for Transfusion.
(Source: What's New at CBER)
Source: What's New at CBER - February 21, 2014 Category: Biomedical Science Source Type: news
Summary Basis for Regulatory Action, December 22, 2013 - Tretten
(Source: What's New at CBER)
Source: What's New at CBER - January 14, 2014 Category: Biomedical Science Source Type: news
November 5, 2013 Approval Letter - Cervarix
(Source: What's New at CBER)
Source: What's New at CBER - November 7, 2013 Category: Biomedical Science Source Type: news
Guidance for Industry: Recommendations for Donor Questioning, Deferral, Reentry and Product Management to Reduce the Risk of Transfusion-Transmitted Malaria
(Source: What's New at CBER)
Source: What's New at CBER - November 5, 2013 Category: Biomedical Science Source Type: news
October 25, 2013 Approval Letter - Menactra
(Source: What's New at CBER)
Source: What's New at CBER - October 29, 2013 Category: Biomedical Science Source Type: news
