abcdefghijklmnopqrstuvwxyz#

Items tagged with DRAFT Files

E2B R3 DRAFT

Updated on 31 December 2011

  • Draft E2B(R3) Electronic Transmission of Individual Case Safety Reports Implementation Guide — Data Elements and Message Specification (version3.01)
  • Version: 3.01 16 June 2011
Download

FDA draft guidance on reponding to information requests

Updated on 29 December 2011

  • Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices
  • Version: December 2011 draft
Download

RMP Draft Guide Australia

Updated on 29 December 2011

  • Draft guidance document for Australian RMPs Dec 2011
  • Version: 1.2
Download

TOME proposal - US

Updated on 29 December 2011

  • The major revamp of US drug safety regulations proposed in 2003
  • Version: 2003 was never implemented
Download

© 2011 Ottosen. All rights reserved.
All site content is provided "as is" and does not represent the views of any organization