Updated EU M1 eCTD Specification
The EU eCTD Module 1 Specification has been updated to v3.1.
EU M1 eCTD Specification v3.1 – Updated Guidelines: Release notes with practical information on changes are provided below. There are also changes to the DTD in this version (version 3.1), and the validation criteria was updated to v8.0 (release notes are also published).
FDA Adverse Event Reporting System (FAERS) Electronic Submissions:
To assist industry when making certain regulatory submissions in electronic format to the FDA’s Adverse Event Reporting System (FAERS) database for the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER).
Statement of Policy Intent: International Recognition of Medical Devices
The UK Medicines and Healthcare products Regulatory Agency (MHRA) aims to facilitate quicker and more efficient access to medical devices by leveraging the expertise and decision-making processes of international regulatory partners. This initiative will benefit patients by allowing the MHRA to recognize approvals from other regulatory bodies, while still retaining the authority to reject applications if the supporting evidence is deemed insufficient.
Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA
Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA: The purpose of this guidance is to provide recommendations for abbreviated new drug applications (ANDAs) or Prior Approval Supplements (PAS) to holders of Type II active pharmaceutical ingredient (API) DMFs.
Requests for Reconsideration at the Division Level Under GDUFA Guidance for Industry
- Appropriate Matter for a Request for Reconsideration?
- Refuse-to-receive decision
- Tentative approval letter