Docket Management
Docket: 01D-0368 - Guidance-Submit Marketing Applications - ICH/CTD Format
Comment Number: EC -1

Accepted - Volume 1

Comment Record
Commentor Mr. Robert Labriola Date/Time 2001-11-01 14:19:27
Organization Millennium Pharmaceuticals, Inc.
Category Company

Comments for FDA General
Questions
1. General Comments Dear Sir or Madame, In reply to the reference, our comments regarding the subject draft guidance document are submitted. 1) The heavy utilization of tabs with numerous references, short in length is cumbersome. It is proposed to allow other alternatives, such as the option of numbering on a contents page (Reference Section III, A, 2, page 4 and Section II, C, 3, page 6.) 2) The draft guidance document discusses the paper document and utilizing no pagination beyond the document level. Not providing sequential numbering is a potential problem for anyone handling the paper document. It is proposed to permit pagination beyond the document level. (Reference Section IV, K, page 12.) Thank you for the opportunity to provide comments. I can be reached at (617) 761-6988 or email labriola@mpi.com if you have any questions or need additional information. Respectfully Submitted, Robert Labriola Associate Director for Regulatory Submissions Worldwide Regulatory Affairs & Pharmacovigilance Millennium Pharmaceuticals, Inc. 75 Sidney Street Cambridge, MA 02139




EC -1