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

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

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