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.
Updated EU eCTD Validation Criteria
The European Medicines Agency (EMA) updated version 7.1 EU eCTD Validation Criteria will come into force September 1, 2018. The changes in the validation criteria relate mainly to change requests received from regulatory bodies and taking experiences with version 6.1 into account.
New 3rd Acknowledgement for ESG Users
Beginning September 4, 2018, a new third Acknowledgement for ESG users will be sent for all submissions sent to the CBER in eCTD format.
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.