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...
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...
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.
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.