News

Latest News | 16 April 2013

eCTD Update Provides Guidance on Use of Image Media in Application

0 Likes

The US Food and Drug Administration (FDA) has issued a new document outlining the process by which sponsors of drug applications should use the electronic Common Technical Document (eCTD), and in Read More...

---

Latest News Regulatory Update | 20 March 2013

Health Canada Moving to Electronic Only Format

1 Likes

Health Canada has announced that as of 1 June 2013, all “administrative regulatory” submissions must be in electronic format only, submitted either as an electronic common technical document (eCTD) or Read More...

---

Latest News | 12 March 2013

PhRMA, BIO, GSK Call on FDA to Alter eCTD Draft Guidance

1 Likes

Some of the largest entities in the pharmaceutical industry, including pharmaceutical manufacturer GlaxoSmithKline and industry trade groups BIO and PhRMA, are weighing in on a recent draft guidance Read More...

---

Latest News | 12 February 2013

Electronic CTD Document Updates to Now Allow Information about Medical Devices, FDA Says

0 Likes

US Food and Drug Administration (FDA) officials have announced the availability of newly revised final documents that describe the recommended process for regulatory professionals to use when Read More...

---

Latest News | 29 January 2013

FDA Signs onto ICH Guidance on E3 Guideline

1 Likes

The US Food and Drug Administration (FDA) has released a new final guidance for industry explaining the E3 Structure and Content of Clinical Study Reports guideline, part of ongoing efforts by Read More...

---

Latest News | 15 January 2013

EMA Launches Full eCTD Submission Platform for Human Medicines Applications

0 Likes

The European Medicines Agency (EMA) has launched its eSubmission Gateway and a new eSubmission web client for the submission of applications for human medicines, it announced on 15 January 2013.The Read More...

---

Latest News | 3 January 2013

In Shift, FDA to Require eCTD for all NDA, ANDA, BLA and IND Submissions

0 Likes

A long-awaited draft guidance requiring the submission of most pharmaceutical and biological product applications to be done using the electronic common technical document (eCTD) standard has been Read More...

---

Latest News | 19 November 2012

FDA Announces Adoption of ICH's Q11 Manufacturing Guideline

1 Likes

The US Food and Drug Administration (FDA) has announced its adoption of the International Conference on Harmonization's Q11 guideline on the development and manufacture of biological and chemical Read More...

---

Latest News | 9 October 2012

Australia to Launch Consultation on Development of eCTD Guidelines, Timetable

2 Likes

Australia's Therapeutic Goods Administration (TGA) is preparing to establish procedures, guidelines and a timetable for the implementation of the submission of medicine applications using the Read More...

---

Latest News | 11 September 2012

Health Canada Overhauls Guidance for eCTD Module

0 Likes

Health Canada has released a new guidance document pertaining to the creation of the Canadian Module 1 backbone of the electronic Common Technical Document (eCTD), a standardized pharmaceutical review Read More...

---