Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) from Adipose Tissue: Regulatory Considerations; Draft Guidance for Industry
This is the Draft Guidance for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) from Adipose Tissue: Regulatory Considerations; Draft Guidance for Industry (Source: What's New at CBER)
Source: What's New at CBER - October 13, 2017 Category: Biomedical Science Source Type: news
Package Insert - TWINRIX
(Source: What's New at CBER)
Source: What's New at CBER - October 3, 2017 Category: Biomedical Science Source Type: news
SOPP 8406: CBER Processing of PDUFA Application Payments
This document describes the procedures used to determine the accuracy of information submitted by an applicant and to verify user fee payments relative to the Prescription Drug User Fee Act (PDUFA) of 1992, as reauthorized by the Food and Drug Administration Amendments Act of 2007. In addition, this document identifies other user fee activities for which the Office of Management ’s Regulatory Information Management Staff (RIMS) is responsible. (Source: What's New at CBER)
Source: What's New at CBER - September 29, 2017 Category: Biomedical Science Source Type: news
Anti-B (Murine Monoclonal)
(Source: What's New at CBER)
Source: What's New at CBER - September 28, 2017 Category: Biomedical Science Source Type: news
Privigen
(Source: What's New at CBER)
Source: What's New at CBER - September 18, 2017 Category: Biomedical Science Source Type: news
Abbott Prism Chagas
The ABBOTT PRISM Chagas assay is an in vitro chemiluminescent immunoassay (ChLIA) for the qualitative detection of antibodies to Trypanosoma cruzi (T cruzi), the causative agent of Chagas disease, in human serum and plasma specimens. (Source: What's New at CBER)
Source: What's New at CBER - September 11, 2017 Category: Biomedical Science Source Type: news
WinRho SDF Liquid
Updated Package Insert, Patient Information and " Dear Healthcare Provider " Letter with Drug Warning Information. Updated: January 26, 2010. (Source: What's New at CBER)
Source: What's New at CBER - September 8, 2017 Category: Biomedical Science Source Type: news
Diphtheria and Tetanus Toxoids Adsorbed
(Source: What's New at CBER)
Source: What's New at CBER - August 28, 2017 Category: Biomedical Science Source Type: news
Benefix
(Source: What's New at CBER)
Source: What's New at CBER - August 28, 2017 Category: Biomedical Science Source Type: news
ReFacto
(Source: What's New at CBER)
Source: What's New at CBER - August 28, 2017 Category: Biomedical Science Source Type: news
TachoSil
(Source: What's New at CBER)
Source: What's New at CBER - August 24, 2017 Category: Biomedical Science Source Type: news
FluLaval Quadrivalent
(Source: What's New at CBER)
Source: What's New at CBER - July 13, 2017 Category: Biomedical Science Source Type: news
EVARREST (Fibrin Sealant Patch)
(Source: What's New at CBER)
Source: What's New at CBER - July 5, 2017 Category: Biomedical Science Source Type: news
Biologics Guidances
(Source: What's New at CBER)
Source: What's New at CBER - July 3, 2017 Category: Biomedical Science Source Type: news
Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 2017
Guidance agenda outling guidance documents CBER is planning to publish during calendar year 2017. (Source: What's New at CBER)
Source: What's New at CBER - July 3, 2017 Category: Biomedical Science Source Type: news
