Rapid Micro Methods Blog

Overview of Current COVID-19 Diagnostic Devices with FDA Emergency Use Authorization

Due to the size of this blog post, we have moved the information to a dedicated page on our website.…

byRapidMicro •March 24, 2020

FDA, CDC, and CMS Launch Task Force to Facilitate Rapid Availability of Diagnostic Tests During Public Health Emergencies

The U.S. Food and Drug Administration, Centers for Disease Control and Prevention (CDC) and the Cent…

byRapidMicro •March 02, 2019

FDA Promotes Rapid Sterility Testing for Human Gene Therapy Products in its Draft Guidance for Investigational New Drug Applications (INDs)

This week, FDA’s Center for Biologics Evaluation and Research (CBER) published six draft guidances r…

byRapidMicro •July 12, 2018

My Opinions on Sage Products Rapid Method Warning Letter (and a reply to Tim Sandle's Blog)

Tim Sandle published a recent blog post concerning a (FDA) Warning Letter related to an inadequate v…

byRapidMicro •September 14, 2017

A Review of the USP Workshop on Alternative Methods

Last week, the USP hosted a workshop on alternative microbiological methods. Dr. Tony Cundell, a m…

byRapidMicro •March 29, 2015

FDA Guidelines Restrict Use of Ebola Scanning Device at Hospitals

It took two days for the US Centers for Disease Control and the Texas Department of State Health…

byRapidMicro •October 24, 2014

FDA Food Safety Challenge to Spur New Technologies for Fighting Foodborne Illness

The U.S. Food and Drug Administration is asking for potential breakthrough ideas on how to find di…

byRapidMicro •September 24, 2014

FDA Addresses Pet Food Safety; Universities Test Raw Pet Food for Salmonella Using PCR

For the first time, the Food and Drug Administration is taking steps to make animal feed and pet f…

byRapidMicro •February 27, 2014

PDA Technical Report No. 33 is Now Available - Webinar on Nov. 6

As the Chairperson of the Technical Report No. 33 task force team, it is my pleasure to announce …

byRapidMicro •October 19, 2013

Comment on a Recent RMM Vendor Roundtable Discussion

In the most recent European Pharmaceutical Review (2013, Vol. 18, Issue 4), two articles provided…

byRapidMicro •September 27, 2013

Introduction to Rapid Microbiological Methods (RMM)

The implementation of rapid methods is increasing in many areas, including pharmaceutical manuf…

byRapidMicro •June 29, 2013

Volume 4 of the Encyclopedia of Rapid Microbiological Methods is Now Available

In January 2013, Volume 4 of the Encyclopedia of Rapid Microbiological Methods was released and t…

byRapidMicro •February 06, 2013

FDA Proposes New Food Safety Standards for Foodborne Illness Prevention and Produce Safety

On January 4, 2013, the U.S. Food and Drug Administration (FDA) proposed two new food safety rul…

byRapidMicro •January 07, 2013