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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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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WebReview – A Simplified eCTD Submission Review Solution
Nov20

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.

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FDA’s New ANDA Submissions Guidance: Key Points
Sep27

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.

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