Regulatory Blog

The Regulatory News you Need to Know,Share & Grow

May 25, 20232 min read

USFDA Guidance: Study Data Technical Conformance Guide - Technical Specifications

Yesterday (24 May, 2023) the United States Food & Drug Administration's Center for Biologics Evaluation and Research (CBER) ánd Center...

Jan 4, 20231 min read

USFDA Guidance: Finalized REMS Format, Content and Technical Conformance Guide

The US Food and Drug Administration (FDA) relaeased finalized the guidance on "Format and Content of a REMS Document" and "REMS Document...

Sep 17, 20221 min read

USFDA Guide: Updated eCTD 4.0 - TECHNICAL CONFORMANCE GUIDE,

Recently USFDA released an updated "Electronic Common Technical Document (eCTD) Technical Conformance Guide" that revised some sections...

May 2, 20221 min read

USFDA Electronic Submission of IND Safety Reports - Technical Conformance Guide

This Document supplements the Guidance Document: Draft Guidance for Industry Providing Regulatory Submissions in Electronic Format: IND...