Docket Management
Docket: 01D-0368 - Guidance-Submit Marketing Applications - ICH/CTD Format
Comment Number: EC -3

Accepted - Volume 1

Comment Record
Commentor Mrs. Andrea Bowne Date/Time 2001-11-05 15:46:49
Organization Purepac Pharmaceutical Co.
Category Company

Comments for FDA General
1. General Comments This is a request for clarification regarding the draft document Guidance for Industry on Submitting Marketing Applications According to the ICH/CTD Format - General Considerations. Purepac Pharmaceutical Co. is specifically concerned with ANDA submissions, and is requesting several clarifications on the draft guidance. There are two references to waivers in the Guidance. In Appendix B, there is a reference to “Waiver of in vivo BA/BE” under ANDAs for Module 5. There is also a reference in Section III.A.3.a (page 5) of the Guidance to a “Waiver requests” for Module 1. However, there is no further reference to a “Waiver requests” in Appendix B under ANDAs in Module 1. Please explain what type of “Waiver requests” would be included in Module 1. Please clarify the difference. In reference to binder colors, on page 10 of the Guidance it states “For ANDAs, the review copy should be red”; however, Table 2 on the following page references the “Review copy for: Clinical – pharmacokinetics and bioavailability” as having an “orange” binder. For an ANDA with a BA/BE study, wouldn’t the submission require a red Quality (CMC) review copy and an orange Clinical BA/BE copy? Please clarify. Also in Table 2 on page 11 of the Guidance, the table header does not reference ANDAs. Does this table apply to ANDAs? As a suggestion, it may be helpful to include a table that describes the number of copies required for each Module. For example: Copies for ANDA Submissions Archival (Blue) Quality Review (Red) BA/BE Review (Orange) Field Review (Green) Module 1 X X X X Module 3 X X N/A X Module 5 X N/A X N/A

EC -3