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Drug Master Files for CBER-Regulated Products
(Source: What's New at CBER)
Source: What's New at CBER - November 21, 2017 Category: Biomedical Science Source Type: news

SOPP 8001.6: Procedures for Parallel Scientific Advice with European Medicines Agency (EMA)- pdf
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 - November 20, 2017 Category: Biomedical Science Source Type: news

Guidance for Industry: Considerations for Allogeneic Pancreatic Islet Cell Products
(Source: What's New at CBER)
Source: What's New at CBER - November 9, 2017 Category: Biomedical Science Source Type: news

Guidance for Industry: Preclinical Assessment of Investigational Cellular and Gene Therapy Products
(Source: What's New at CBER)
Source: What's New at CBER - November 9, 2017 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 - November 9, 2017 Category: Biomedical Science Source Type: news

Draft Guidance for Industry: Same Surgical Procedure Exception under 21 CFR 1271.15(b):  Questions and Answers Regarding the Scope of the Exception
(Source: What's New at CBER)
Source: What's New at CBER - November 9, 2017 Category: Biomedical Science Source Type: news

Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products: Draft Guidance
(Source: What's New at CBER)
Source: What's New at CBER - November 9, 2017 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 - November 9, 2017 Category: Biomedical Science Source Type: news

Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) from Adipose Tissue: Regulatory Considerations; Draft Guidance
(Source: What's New at CBER)
Source: What's New at CBER - November 9, 2017 Category: Biomedical Science Source Type: news

Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products: Draft Guidance for Industry and Food and Drug Administration Staff
This is a Draft Guidance for Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products: Draft Guidance for Industry and Food and Drug Administration Staff (Source: What's New at CBER)
Source: What's New at CBER - October 13, 2017 Category: Biomedical Science Source Type: news

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

Seraclone Blood Grouping Reagent Anti-S (Monoclonal)
(Source: What's New at CBER)
Source: What's New at CBER - June 26, 2017 Category: Biomedical Science Source Type: news

List of Establishments Granted Approval for a Variance to 21CFR640.3(d) and 21CFR640.3(f)
(Source: What's New at CBER)
Source: What's New at CBER - June 20, 2017 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 - June 5, 2017 Category: Biomedical Science Source Type: news

COBAS TaqScreen West Nile Virus Test
(Source: What's New at CBER)
Source: What's New at CBER - June 5, 2017 Category: Biomedical Science Source Type: news

Procleix West Nile Virus (WNV) Assay
(Source: What's New at CBER)
Source: What's New at CBER - June 5, 2017 Category: Biomedical Science Source Type: news

Auszyme Monoclonal
CBER Auszyme Monoclonal Product Approval Information (Source: What's New at CBER)
Source: What's New at CBER - June 5, 2017 Category: Biomedical Science Source Type: news

Procleix HIV-1/HCV Assay
(Source: What's New at CBER)
Source: What's New at CBER - June 5, 2017 Category: Biomedical Science Source Type: news

ORTHO T. cruzi ELISA Test System
(Source: What's New at CBER)
Source: What's New at CBER - June 5, 2017 Category: Biomedical Science Source Type: news

Influenza A (H1N1) 2009 Monovalent Vaccines Composition and Lot Release
Vaccine lot release information updated on 3/3/2010. (Source: What's New at CBER)
Source: What's New at CBER - May 31, 2017 Category: Biomedical Science Source Type: news

Influenza A (H1N1) 2009 Monovalent Vaccines Descriptions and Ingredients
(Source: What's New at CBER)
Source: What's New at CBER - May 31, 2017 Category: Biomedical Science Source Type: news

7345.848 - Inspection of Biological Drug Products
(Source: What's New at CBER)
Source: What's New at CBER - May 23, 2017 Category: Biomedical Science Source Type: news

Measles, Mumps and Rubella Virus Vaccine, Live
(Source: What's New at CBER)
Source: What's New at CBER - May 17, 2017 Category: Biomedical Science Source Type: news

Fluzone Quadrivalent
(Source: What's New at CBER)
Source: What's New at CBER - May 11, 2017 Category: Biomedical Science Source Type: news

Blood Grouping Reagents, Anti-Wra ALBAsera
(Source: What's New at CBER)
Source: What's New at CBER - May 11, 2017 Category: Biomedical Science Source Type: news

Seraclone Blood Grouping Reagent Anti-Fya(Monoclonal)
(Source: What's New at CBER)
Source: What's New at CBER - May 11, 2017 Category: Biomedical Science Source Type: news

CroFab
(Source: What's New at CBER)
Source: What's New at CBER - May 8, 2017 Category: Biomedical Science Source Type: news

BabyBIG
(Source: What's New at CBER)
Source: What's New at CBER - April 28, 2017 Category: Biomedical Science Source Type: news

Thymoglobulin
(Source: What's New at CBER)
Source: What's New at CBER - April 27, 2017 Category: Biomedical Science Source Type: news

Clinical Investigator Status (Biologics)
Clinical Investigator Inspection List from inspections of clinical investigators who have conducted studies with investigational new drugs or investigational devices reviewed by CBER (Source: What's New at CBER)
Source: What's New at CBER - April 20, 2017 Category: Biomedical Science Source Type: news

Exceptions and Alternative Procedures Approved Under 21 CFR 640.120
Title 21 Code of Federal Regulations 640.120(a) - The Director, Center for Biologics Evaluation and Research, may approve an exception or alternative procedures to any requirement in subchapter F (Biologics) of Chapter I (Parts 600 - 680) of title 21 of the Code of Federal Regulations regarding blood, blood components or blood products. Both licensed and unlicensed blood establishments must submit requests for an exception or alternative procedure to the requirements in Parts 600-680. (Source: What's New at CBER)
Source: What's New at CBER - March 28, 2017 Category: Biomedical Science Source Type: news

Zostavax
(Source: What's New at CBER)
Source: What's New at CBER - March 16, 2017 Category: Biomedical Science Source Type: news

Complete List of Substantially Equivalent 510(k) Device Applications
Information updated through January 31, 2017 (Source: What's New at CBER)
Source: What's New at CBER - March 16, 2017 Category: Biomedical Science Source Type: news

Afluria
(Source: What's New at CBER)
Source: What's New at CBER - March 15, 2017 Category: Biomedical Science Source Type: news

RotaTeq
(Source: What's New at CBER)
Source: What's New at CBER - March 14, 2017 Category: Biomedical Science Source Type: news

Infanrix
(Source: What's New at CBER)
Source: What's New at CBER - March 14, 2017 Category: Biomedical Science Source Type: news