Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 2019
Guidance agenda outling guidance documents CBER is planning to publish during calendar year 2019. (Source: What's New at CBER)
Source: What's New at CBER - February 20, 2019 Category: Biomedical Science Source Type: news
Manufacturers Assistance and Technical Training Branch (MATTB)
CBER ’s Manufacturers Assistance and Technical Training Branch (MATTB) responds to public inquiries for information (by phone and email) from the biologics industry. MATTB strives to provide timely, accurate and useful information to stakeholders. (Source: What's New at CBER)
Source: What's New at CBER - June 6, 2018 Category: Biomedical Science Source Type: news
CBER-Regulated Products: Shortages and Discontinuations
A CBER-regulated product shortage occurs when a CBER-regulated product is not commercially available in sufficient quantity to meet the demand. (Source: What's New at CBER)
Source: What's New at CBER - March 28, 2018 Category: Biomedical Science Source Type: news
SOPP 8001.6: Procedures for Parallel Scientific Advice with European Medicines Agency (EMA)
This is the CBER SOPP 8001.6: Procedures for Parallel Scientific Advice with European Medicines Agency (EMA). (Source: What's New at CBER)
Source: What's New at CBER - March 27, 2018 Category: Biomedical Science Source Type: news
Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)
List of Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) products (Source: What's New at CBER)
Source: What's New at CBER - March 26, 2018 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 - March 23, 2018 Category: Biomedical Science Source Type: news
Keeping Blood Transfusions Safe: FDA's Multi-layered Protections for Donated Blood
(Source: What's New at CBER)
Source: What's New at CBER - March 23, 2018 Category: Biomedical Science Source Type: news
Cord Blood Banking - Information for Consumers
(Source: What's New at CBER)
Source: What's New at CBER - March 23, 2018 Category: Biomedical Science Source Type: news
Osiris Therapeutics, Inc. - Untitled Letter
(Source: What's New at CBER)
Source: What's New at CBER - March 23, 2018 Category: Biomedical Science Source Type: news
CBER ’s Sentinel Program
(Source: What's New at CBER)
Source: What's New at CBER - March 22, 2018 Category: Biomedical Science Source Type: news
CBER ’ s Sentinel Program
(Source: What's New at CBER)
Source: What's New at CBER - March 22, 2018 Category: Biomedical Science Source Type: news
September 23, 2013 Approval Letter - GAMMAGARD S/D
. (Source: What's New at CBER)
Source: What's New at CBER - March 6, 2018 Category: Biomedical Science Source Type: news
Zoster Vaccine, Live
(Source: What's New at CBER)
Source: What's New at CBER - March 1, 2018 Category: Biomedical Science Source Type: news
Yellow Fever Vaccine
CBER Approved Product For active immunization of persons 9 months of age and older who:
•Are living in or traveling to endemic areas;
•Travelling internationally to countries that require evidence of vaccination from entering travelers or;
•Laboratory Personnel who might be expose to virulent yellow fever virus or to concentrated preparations of the yellow fever vaccine strain b y direct or indirect contact or by aerosols should by vaccinated. (Source: What's New at CBER)
Source: What's New at CBER - March 1, 2018 Category: Biomedical Science Source Type: news
Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed
(Source: What's New at CBER)
Source: What's New at CBER - March 1, 2018 Category: Biomedical Science Source Type: news
