Docket Management
Docket: 01D-0475 - Draft Guidance-Regulatory Submissions in Electronic Format-ANDAs
Comment Number: EC -3

Accepted - Volume 1

Comment Record
Commentor Mrs. Andrea Bowne Date/Time 2002-01-17 13:21:50
Organization Purepac Pharmaceutical Co.
Category Company

Comments for FDA General
1. General Comments This is a request for clarification regarding the draft Guidance for Industry, Providing Regulatory Submissions in Electronic Format-ANDAs. Purepac Pharmaceutical Co. is particularly concerned about the differences between the proposed electronic format described in this draft guidance, and the proposed format described in the ICH draft Guidance on Electronic Common Technical Document Specification (eCTD). Which Guidance will take precedence? Also, please note on page 4 Section III.A. of the guidance, there are in fact six (6) subfolders inside the main ANDA folder.

EC -3