FDA Renews Licenses for Synchrogenix’s GlobalSubmit eCTD Software
The US FDA has renewed its legacy licenses for Synchrogenix's eCTD review and validation software, GlobalSubmit REVIEW and GlobalSubmit VALIDATE for another year. The post FDA Renews Licenses for...
View ArticleFinal Guidance Includes eCTD Implementation Date for Promotional Materials...
Final Guidance and Implementation Date The U.S. Food and Drug Administration (FDA) has released long-anticipated final guidance with the implementation date for all promotional materials submissions...
View ArticleAttending DIA 2019? Come See Us!
DIA is an opportunity to share challenges, strategies, and other insights to advance our common goal of achieving regulatory success. As one of our valued eCTD Summit community members, we hope you'll...
View ArticleHealth Canada eCTD Update
Health Canada announced an update to the mandatory use of the electronic Common Technical Document (eCTD) format. As of June 1, 2019, the remainder of Division 8 regulatory activity types (human drugs...
View ArticleDIA’s RSIDM 2019: Highlights from the ‘Ask the Regulators’ Sessions
Synchrogenix was well represented at DIA’s Annual Regulatory Submissions, Information, and Document Management (RSIDM) Forum held earlier this month. One of the reasons RSIDM is such a valuable meeting...
View ArticleWebReview – A Simplified eCTD Submission Review Solution
WebReview is a simple, secure solution that works on any operating system and any browser – no installations, no upgrades – just easy anytime, anywhere access. That includes the homes of those working...
View ArticleFDA Requirements for Providing Datasets for Nonclinical Studies in SEND Format
The CDISC Standard for the Exchange of Nonclinical Data (SEND) provides the structure and implementation rules for the submission of computer readable datasets. SEND is one of the required standards...
View ArticleFDA’s New ANDA Submissions Guidance: Key Points
The U.S. Food and Drug Administration (FDA) published notice of a new ANDA submissions guidance on September 24. The final guidance for industry titled, "ANDA Submissions - Content and Format" is...
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 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 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 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 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 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 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 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 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 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 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 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...
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