Kogenate FS
(Source: What's New at CBER)
Source: What's New at CBER - March 2, 2017 Category: Biomedical Science Source Type: news

Tisseel
(Source: What's New at CBER)
Source: What's New at CBER - March 2, 2017 Category: Biomedical Science Source Type: news

Gammagard Liquid
(Source: What's New at CBER)
Source: What's New at CBER - March 2, 2017 Category: Biomedical Science Source Type: news

Rhophylac
(Source: What's New at CBER)
Source: What's New at CBER - March 1, 2017 Category: Biomedical Science Source Type: news

Patient Touch ™ Blood Product Administration System v3.2.1
Stand Alone, Blood Bank Software (Source: What's New at CBER)
Source: What's New at CBER - February 24, 2017 Category: Biomedical Science Source Type: news

Patient Touch ™ Blood Product Administration System v3.2.1
Stand Alone, Blood Bank Software (Source: What's New at CBER)
Source: What's New at CBER - February 24, 2017 Category: Biomedical Science Source Type: news

Gammaplex 5% & 10%
October 7, 2009 letter corrects the storage temperature stated on page 1, paragraph 5. Posted: 12/11/2009 (Source: What's New at CBER)
Source: What's New at CBER - February 7, 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 - January 18, 2017 Category: Biomedical Science Source Type: news

December 5, 2012: Blood Products Advisory Committee: Errata – FDA Briefing Document
(Source: What's New at CBER)
Source: What's New at CBER - October 13, 2016 Category: Biomedical Science Source Type: news

Diphtheria and Tetanus Toxoids Adsorbed
(Source: What's New at CBER)
Source: What's New at CBER - August 5, 2016 Category: Biomedical Science Source Type: news

Patient Touch™ Blood Product Administration System v3.2.1
Stand Alone, Blood Bank Software (Source: What's New at CBER)
Source: What's New at CBER - April 22, 2016 Category: Biomedical Science Source Type: news

Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry
. (Source: What's New at CBER)
Source: What's New at CBER - March 14, 2016 Category: Biomedical Science Source Type: news

Flebogamma DIF 5% & 10%
Updated Package Insert, December 2009. (Source: What's New at CBER)
Source: What's New at CBER - January 22, 2016 Category: Biomedical Science Source Type: news

Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 2016
Guidance agenda outling guidance documents CBER is planning to publish during calendar year 2016. (Source: What's New at CBER)
Source: What's New at CBER - January 14, 2016 Category: Biomedical Science Source Type: news

October 27, 2015 Approval Letter - IMLYGIC
IMLYGIC is a genetically modified oncolytic viral therapy indicated for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery. (Source: What's New at CBER)
Source: What's New at CBER - November 4, 2015 Category: Biomedical Science Source Type: news

Vaccines Licensed for Immunization and Distribution in the US with Supporting Documents
This list includes only vaccines for which supporting documents were provided and is arranged alphabetically by the proper name of the product. Information is provided for original product approvals, new indications, and the current package insert. For a complete list of approved vaccines, click the link under "Related Information" at the bottom of this page. (Source: What's New at CBER)
Source: What's New at CBER - August 19, 2015 Category: Biomedical Science Source Type: news

Order to Cease Manufacturing and to Retain HCT/Ps - Donor Referral Services
(Source: What's New at CBER)
Source: What's New at CBER - August 17, 2015 Category: Biomedical Science Source Type: news

Approval History, Letters, Reviews, and Related Documents - TRETTEN
(Source: What's New at CBER)
Source: What's New at CBER - July 22, 2015 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 - June 11, 2015 Category: Biomedical Science Source Type: news

Bar Code Requirements for Blood Banks
(Source: What's New at CBER)
Source: What's New at CBER - June 10, 2015 Category: Biomedical Science Source Type: news

U.S. Food and Drug Administration Regulation of Human Cells, Tissues, or Cellular or Tissue-Based Products (HCT/Ps)
(Source: What's New at CBER)
Source: What's New at CBER - June 10, 2015 Category: Biomedical Science Source Type: news

FDA Update: Relevant to Reproductive Establishments
(Source: What's New at CBER)
Source: What's New at CBER - June 10, 2015 Category: Biomedical Science Source Type: news

FDA Update
(Source: What's New at CBER)
Source: What's New at CBER - June 10, 2015 Category: Biomedical Science Source Type: news

October 11, 2007 Transcripts
(Source: What's New at CBER)
Source: What's New at CBER - June 10, 2015 Category: Biomedical Science Source Type: news

October 12, 2007 Transcripts
(Source: What's New at CBER)
Source: What's New at CBER - June 10, 2015 Category: Biomedical Science Source Type: news

July 22, 2004 Approval Letter
(Source: What's New at CBER)
Source: What's New at CBER - June 10, 2015 Category: Biomedical Science Source Type: news

CBER’s Sentinel Program
(Source: What's New at CBER)
Source: What's New at CBER - April 17, 2015 Category: Biomedical Science Source Type: news

Determining the Need for and Content of Environmental Assessments for Gene Therapies, Vectored Vaccines, and Related Recombinant Viral or Microbial Products; Guidance for Industry
(Source: What's New at CBER)
Source: What's New at CBER - March 23, 2015 Category: Biomedical Science Source Type: news

CBER FY 2013 Recall Postings
(Source: What's New at CBER)
Source: What's New at CBER - March 12, 2015 Category: Biomedical Science Source Type: news

Package Insert and Patient Information - Rotarix
CBER Rotarix Product Approval Information (Source: What's New at CBER)
Source: What's New at CBER - March 2, 2015 Category: Biomedical Science Source Type: news

Biologics Guidances
(Source: What's New at CBER)
Source: What's New at CBER - February 24, 2015 Category: Biomedical Science Source Type: news

Generics
(Source: What's New at CBER)
Source: What's New at CBER - February 24, 2015 Category: Biomedical Science Source Type: news

Investigating and Reporting Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Regulated Solely under Section 361 of the Public Health Service Act and 21 CFR Part 1271; Draft Guidance
(Source: What's New at CBER)
Source: What's New at CBER - February 19, 2015 Category: Biomedical Science Source Type: news

Investigating and Reporting Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Regulated Solely under Section 361 of the Public Health Service Act and 21 CFR Part 1271 - Draft
(Source: What's New at CBER)
Source: What's New at CBER - February 18, 2015 Category: Biomedical Science Source Type: news

Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 2015
(Source: What's New at CBER)
Source: What's New at CBER - January 23, 2015 Category: Biomedical Science Source Type: news

Influenza Virus Vaccine, H5N1 (for National Stockpile)
(Source: What's New at CBER)
Source: What's New at CBER - January 15, 2015 Category: Biomedical Science Source Type: news

DigiFab
(Source: What's New at CBER)
Source: What's New at CBER - January 15, 2015 Category: Biomedical Science Source Type: news

CroFab
(Source: What's New at CBER)
Source: What's New at CBER - January 15, 2015 Category: Biomedical Science Source Type: news

Gammagard Liquid
(Source: What's New at CBER)
Source: What's New at CBER - January 15, 2015 Category: Biomedical Science Source Type: news

Privigen
(Source: What's New at CBER)
Source: What's New at CBER - January 15, 2015 Category: Biomedical Science Source Type: news

Gamunex-C
(Source: What's New at CBER)
Source: What's New at CBER - January 15, 2015 Category: Biomedical Science Source Type: news

Octagam
(Source: What's New at CBER)
Source: What's New at CBER - January 15, 2015 Category: Biomedical Science Source Type: news

Abbott prism htlv-i/htlv-ii
The ABBOTT PRISM HTLV-I/HTLV-II assay is an in vitro chemiluminescent immunoassay (ChLIA) for the qualitative detection of antibodies to human T-lymphotropic virus Type I and/or human T-lymphotropic virus Type II (anti-HTLV-I/ HTLV-II) in human serum and plasma specimens. The ABBOTT PRISM HTLV-I/HTLV-II (ChLIA) is intended to screen individual human donors, including volunteer donors of whole blood and blood components, and other living donors for the presence of anti-HTLV-I/HTLV-II. It is also intended for use in testing blood and plasma specimens to screen organ donors when specimens are obtained while the donor’s ...
Source: What's New at CBER - January 15, 2015 Category: Biomedical Science Source Type: news

ABBOTT HIVAB HIV-1/HIV-2 (rDNA) EIA
HIVAB HIV-1/HIV-2 (rDNA) EIA is an in vitro enzyme immunoassay for the qualitative detection of antibodies to human immunodeficiency viruses type 1 and/or type 2 (HIV-1/HIV-2) in human serum, plasma, or cadaveric serum (Source: What's New at CBER)
Source: What's New at CBER - January 15, 2015 Category: Biomedical Science Source Type: news

Procleix HIV-1/HCV Assay
(Source: What's New at CBER)
Source: What's New at CBER - January 15, 2015 Category: Biomedical Science Source Type: news

HepaGam B
(Source: What's New at CBER)
Source: What's New at CBER - January 13, 2015 Category: Biomedical Science Source Type: news

Nabi-HB
(Source: What's New at CBER)
Source: What's New at CBER - January 13, 2015 Category: Biomedical Science Source Type: news

Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)
(Source: What's New at CBER)
Source: What's New at CBER - January 13, 2015 Category: Biomedical Science Source Type: news

Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine
(Source: What's New at CBER)
Source: What's New at CBER - January 13, 2015 Category: Biomedical Science Source Type: news

Ceprotin
(Source: What's New at CBER)
Source: What's New at CBER - December 31, 2014 Category: Biomedical Science Source Type: news