Labeling

Early Preparations for Your Establishment Registration SPL

When the conversation turns to Structured Product Labeling (SPL) our first thought is often about Prescribing Information. But as the US FDA and other regulatory bodies modernize review processes, electronic submissions are having an impact across more and more communications. Establishment Registration is one of the more critical SPL submissions and must be submitted annually to the FDA in a… Read more →

GlobalSubmit Presents eCTD Essentials in Multiple Cities this October

In recent years eCTD has become the preferred format for regulatory submissions worldwide, and momentum continues to build as mandates take effect in Europe and the United States. Compiling an electronic regulatory submission is a challenging task even for industry veterans who’e worked on multiple projects. Naturally, an organization making the transition from paper to electronic format or compiling a… Read more →

eCTD News Roundup: Online Articles, Standards News, and Conferences

A number of good articles related to eSubmissions have been posted online recently.  Below, a recap based on posts from my twitter account, www.twitter.com/kathie_clark.   Even Richardson of Cato Research posted a useful blog entry, Bookmarks – Collapsed or Expanded? On the “Ask Cato” blog.  The entry discusses the FDA reviewers’ preferences for the default expansion of PDF bookmarks. Pharma… Read more →

News Roundup Part 1: Agency News

Today’s post is a round-up of recent eSubmission-related news from the agencies, based on posts from my twitter account, www.twitter.com/kathie_clark.  Next time, a roundup of articles and conferences. The regulatory authorities haven’t put out much in the way of major updates recently, but there have been some updates worth noting: ICH issued a new valid-values.xml for study tagging files see… Read more →

Agency News, Documents and Presentations (Recent eCTD and eSubmissions News Part 2)

As promised, here is an expanded list of posts published recently on my twitter account, this time related to agency news: CMD(h) issued a new Best Practice Guide on the use of eCTD in the MRP/DCP. Dr Martin Moxham of iRegulatory provided an excellent review of the updated CMDh best practice guide. CMDh also posted Contact E-Mail Addresses For Submission… Read more →