eCTD submission

US FDA will be accepting eCTD submission with U.S. Regional DTD V3.3 only from 1st March 2022

The US Food and Drug Administration’s (FDA or Agency) has announced the date that they will no longer support electronic submissions using the Electronic Common Technical Document (eCTD) Backbone Files Specification for Module 1 Version 1.3, Comprehensive Table of Contents Headings and Hierarchy Version 1.2.2, U.S. Regional Document Type Definition (DTD) Version 2.01 after March 1, […]

Regulatory

Cross Labeling Oncology Drugs in Combination Regimens Draft Guidance Issued by FDA

Cross labeling guidance is in response to increasing requests from sponsors applying for oncology drugs intended to be used in combination regimens. The purpose of this guidance is to describe FDA’s current recommendations about including relevant information in labeling for oncology drugs approved for use in a combination regimen, including important considerations for cross labeling […]