We have very recently updated all of our rapidmicromethods.com Regulatory Pages to better reflect the most current perspectives, expectations and guidance from the U.S. FDA, EMA, Australian TGA, Japanese PMDA, ICH, as well as added an expanded page that discusses the regulatory impact of changing acceptance levels and microbial specifications. Please visit our Regulatory starting page at http://rapidmicromethods.com/files/regulatory.html. Links to each section can be found at the top of this page.Look for more revisions to our website in the upcoming month, especially in the area of available technologies and implementation strategies. Our Blog and Newsletter will announce when our updates are effective (you can sign up for our FREE monthly newsletter at http://rapidmicromethods.com/newsletter/).