News

NAT Testing of West Nile Virus from Human Cells and Tissues

As a part of their continuous review of new data related to West Nile Virus, the FDA published a Draft Guidance for Industry: Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Donors of Human Cells, Tissues, and Cellular and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). Read more.

More
FDA publishes ICH Q4B Annex 14 for Interchangeable Endotoxin Testing between ICH Regions

The US FDA adopted the "ICH Guideline Q4B Annex 14 to note for evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on bacterial endotoxins tests - general chapter". Read more.

More
PDA TR33 Evaluation, Validation and Implementation of Alternative and Rapid Microbiological Methods

The Parenteral Drug Association published the revised Technical Report No. 33 on Alternative and Rapid Microbiological Methods. Read more here.

More
U.S. FDA Clearance for Mass Spectrometry

bioMérieux announces U.S. FDA Clearance for VITEK® MS, a revolutionary technology which reduces microbial identification from days to minutes. Further details can be found here.

More
Rapid Microbio Methods Database updated with new systems

The Rapid Microbiological Methods database in the member area of our working group was updated with 3 new systems. For more information please see this news.

More
Use of Nucleic Acid Tests

With this guidance, the FDA addresses blood establishments that collect Whole Blood and blood components for transfusion or for further manufacture. Read on.

More
FDA-approval for Roche’s nucleic acid based (PCR) Rapid Mycoplasma Test (MycoTOOL® PCR Mycoplasma Detection Kit)

On November 1st, 2012, the MycoTOOL® PCR Mycoplasma Detection Kit-based test from Roche Applied Science was approved by the U.S. Food and Drug Administration (FDA) for release testing of a  Roche biopharmaceutical product. More details here.

More
New guideline for DNA Sequences could prevent erroneous Data

A international team of researchers, with it’s core at the University of Gothenburg, Sweden, has prepared a guide to assist the scientific community in the quality control process. Find out more.

More
Revision of USP 1223 - current Status

The Vice-Chair of the USP General Chapters – Microbiology Expert Committee, Tony Cundell, recently provided an update to the chapter’s revision process and what we should see when the draft is published in a future issue of the Pharmacopeial Forum. Read more.

More
Rapid Micro Biosystems announces Availability of Growth Direct System

New applications should improve the efficiency of microbial quality control processes while significantly reducing the time-to-result. More details can be found here.

More
x
Search