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.
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 forward to the “Ask the Regulators” sessions, where FDA representatives answer questions directly from the attendees. Following are highlights from the ‘Ask the Regulators’ sessions.
WebReview – 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 remotely and even the business center at the Bahamian resort where one of your reviewers is vacationing. Gone are the days of being limited by installs, licenses and platform preferences.
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 overall package consists of several components, but the focus is on individual study endpoint data which are typically mapped to datasets in domains with several variables in each study dataset.
Reminder: Establishment Registration Renewals are Due by EOY
FDA Establishment Registration renewals for 2019 must be submitted between October 1 and December 31. With certain exemptions, any establishment engaged in the manufacture, repacking, relabeling, or salvaging of a drug product for commercial distribution is required to register with FDA annually. Registration is required within five days of introducing a product into commercial distribution.
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 abbreviated new drug applications (ANDAs) for submission to FDA. The primary purpose of this guidance is to help industry increase the quality and suitability of electronic common technical document (eCTD) submissions by identifying the information that an applicant should include to ensure that a complete, high-quality application is submitted to FDA.