Tag: eCTD
New FDA Initiatives: Project Orbis and Real-Time Oncology Review
The U.S. Food and Drug Administration (FDA) recently announced two exciting and innovative initiatives from FDA’s Oncology Center of Excellence: Project Orbis and Real-Time Oncology Review (RTOR) Pilot Program. Project Orbis Project Orbis, an initiative of the FDA Oncology Center of Excellence (OCE), will provide a framework for concurrent submission and review of oncology products between international … Continued
Final Guidance Includes eCTD Implementation Date for Promotional Materials Submissions
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 via electronic common technical document (eCTD) format. The guidance titled, “Providing Regulatory Submissions in Electronic and Non-Electronic Format — Promotional Labeling and Advertising Materials for Human Prescription Drugs” defines … Continued
DIA’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 for Regulatory Operations professionals is because it is so well attended by U.S. FDA staff members who participate both as speakers and fellow attendees. We particularly look … Continued
FDA 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 for data submission to the U.S. Food and Drug Administration (FDA) and specifies a way to collect and present nonclinical data in a consistent format. The … Continued
FDA’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 intended to assist applicants in preparing complete and fileable abbreviated new drug applications (ANDAs) for submission to FDA. The primary purpose of this guidance is to … Continued
Study 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 provides three options to choose from – short, medium, and long. But the ICH eCTD STF Specification doesn’t define the time periods covered by … Continued
Updated EU eCTD Validation Criteria
The European Medicines Agency (EMA) updated version 7.1 EU eCTD Validation Criteria will come into force 2018年9月1日. The changes in the validation criteria relate mainly to change requests received from regulatory bodies and taking experiences with version 6.1 into account. Click here for the Release Notes for the EU eCTD Validation Criteria version … Continued
Updated Form FDA 1571
FDA has updated Form FDA 1571 again and posted a new version to the FDA Forms web page, replacing the previous version, released in April 2018. This new version includes a revision date of “(07/18)” in the footer of each page. A side by side comparison of this July 2018 version to the previous version … Continued
Updates to Common FDA Forms
We recently posted about the August 2017 updates to common FDA forms included in eCTD submissions. Well, they’ve been updated yet again. Several FDA forms are now showing a revision date of April 2018, including: Form FDA 356h Form FDA 1571 Form FDA 3674 The easiest way to ensure that you’re using the current version of … Continued
