Five Points to Consider When Selecting an Enterprise eCTD Viewer
When selecting a system for cross-department viewing of eCTD submissions, as well as archiving, here are some important points you’ll want to give proper attention. The post Five Points to Consider...
View ArticleHow Unwritten Agency Rules Affect eCTD System Migration
The true challenge of eCTD migration is your impact analysis (i.e. downtime, architectural changes and environmental changes) and determining whether or not your selected vendor supports unwritten...
View ArticleA Look at FDA Submission Metrics for Module 1
Submissions metrics for the US FDA's new Module 1 shared with industry at the DIA RSIDM 2016 Forum paint a picture of modest activity for the enhanced specification. As of February 1, 2016, 117...
View ArticleAdvertising and Promotional Submissions Exempt from Coming eCTD Mandate
The FDA requirement to submit in eCTD format as of May 5, 2017 does not apply to Ad Promo submissions. As of today, the timeline for requirement of these submissions in eCTD is to be determined....
View ArticleFDA eCTD Mandate: One Year and Counting
Almost five years ago, I wrote a post outlining the process for converting a paper application into an eCTD application with FDA. As the saying goes, the more things change, the more they stay the...
View ArticleDissecting eCTD 4
Much fanfare has surrounded the Next Major Version (NMV) of eCTD or eCTD 4 since the group I chaired formed in 2005 and developed initial requirements for the standard. You’ve likely sat in on eCTD 4...
View ArticleDocument Reuse, Lifecycle and Metadata Overhauled in eCTD v4.0
The focal points of eCTD v4.0 like document reuse, enhanced lifecycle control and more liberal use of metadata, and the ability to alter that metadata if errors are made, are countermeasures to the...
View ArticleScanning, a Thing of the Past
Nowadays the word “scan” is a bad word. Scanned documents are more difficult to read and often the quality is lower. Further, scanned documents do not allow search or copy and paste text. During an...
View ArticleHealth Canada Revises Rules for eCTD Submissions
Health Canada recently announced revised validation rules for regulatory transactions for electronic Common Technical Document (eCTD) submissions. The post Health Canada Revises Rules for eCTD...
View ArticleFDARA Marketing Status Reports Due
Time is running out for an item that may require your regulatory compliance attention. By law, FDARA marketing status reports are due on or before February 14, 2018. The post FDARA Marketing Status...
View ArticleIs Your Company Prepared for the FDA eCTD Mandate?
Here we are in 2018, and to the surprise of some and the consternation of many, some paper applications are still alive and well. However, their days are numbered. The May FDA eCTD mandate is upon us....
View ArticleTips For A Successful eCTD Conversion
With the May, 2018 FDA mandate quickly approaching, conversion of paper IND's, NDA's, and DMF's to eCTD format must happen soon. Here are some tips for a successful eCTD conversion. The post Tips For A...
View ArticleDIA’s RSIDM Ask The Regulators Session: What We Learned
DIA’s Annual Regulatory Submissions, Information, and Document Management (RSIDM) Meeting is an excellent opportunity to learn the latest eCTD information and best practices. One of the most valuable...
View ArticleThinking Beyond eCTD Publishing
While finding the right publishing vendor provides tremendous value to an organization short on internal resources, it is important to be thinking beyond eCTD publishing. Pairing with a vendor that can...
View ArticleNew FDA Forms 356h and 1571
In August 2017, FDA updated both the Form FDA 356h (Application to Market a New Drug, Biologic or an Antibiotic Drug for Human Use) and the Form FDA 1571 (Investigational New Drug Application) to...
View ArticleNeeS: A Thing of the Past
With 2018 well underway, if you're still not submitting in electronic Common Technical Document (eCTD) format in Europe, now is the time to transition. Non-eCTD electronic Submission or “NeeS” have...
View ArticleTrial Summary Dataset: An Overview
The Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM) Trial Summary dataset has become increasingly useful to reviewers. The Trial Summary (TS) dataset allows...
View ArticleNew 3rd Acknowledgement for ESG Users
Beginning September 4, 2018, a new third Acknowledgement for ESG users will be sent for all submissions sent to the CBER in eCTD format. The post New 3rd Acknowledgement for ESG Users appeared first on...
View ArticleUpdated EU eCTD Validation Criteria
The European Medicines Agency (EMA) updated version 7.1 EU eCTD Validation Criteria will come into force September 1, 2018. The changes in the validation criteria relate mainly to change requests...
View ArticleStudy Tagging Files: What’s the Right Duration for Study Metadata?
When submitting nonclinical study reports in regions using Study Tagging Files (STF), the duration of the study is one common piece of metadata that must be provided. The ICH eCTD STF Specification...
View Article
![Raveena – Blissed Out – Single [iTunes Plus M4A]](http://i.imgur.com/03XzSQn.jpeg)
