New FDA Initiatives: Project Orbis and Real-Time Oncology Review
Oct30

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 partners. The...

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FDA Renews Licenses for Synchrogenix’s GlobalSubmit eCTD Software
Sep25

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.

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FDA Inactivating Drug Listing Records
Sep11

FDA Inactivating Drug Listing Records

Last month the Food and Drug Administration (FDA) announced its intention to inactivate drug listings for drugs intended for human use that are improperly listed. Reasons that a listing may be considered incomplete and therefore be inactivated include: absence of an annual certificationmissing identification of a manufacturing establishment Drug listings not in accordance with FDA requirements are not certified as being active and up...

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Final Guidance Includes eCTD Implementation Date for Promotional Materials Submissions
Aug05

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...

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Attending DIA 2019? Come See Us!
Jun19

Attending 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 schedule a meeting with us or visit our booth #1117, which is sure to be a premium destination at DIA 2019.

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Health Canada eCTD Update
Mar13

Health 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 only) must be submitted in eCTD format.

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