| Comment Record|
Mr. Francisco N ||
2001-11-05 17:09:05 |
Hoffmann-La Roche |
| Comments for FDA General |
1. General Comments
1. COMMENTS ON THE PAPER CTD GUIDELINE :
The US industry is gearing up for, or is already producing electronic compliant dossiers, therefore the proposed guideline mainly focusing on paper submissions does not address in sufficient detail the differences and alternatives for filing CTD in electronic format (.pdf). Roche along with most of the industry has been working vigorously to comply with the Electronic Submissions guidelines (Providing Regulatory Submissions in Electronic Format – CDER & CBER, January 1999), and feels that a change back to a paper based submission in the US, would be extremely inefficient.
A Guidance detailing how CTD can be submitted in electronic form (.pdf) is extremely important for the industry, in the making of the right decisions and setting up the processes for compliance with the electronic submission guidelines and CTD requirements, until eCTD guidelines are introduced. With that, an FDA sample structure of what a CTD in electronic format would look like, would present many benefits for the industry. .
Does the FDA plan to provide the industry with a sample structure outline of how to submit CTD in electronic format?
2. COMMENTS ON CROSS-REFERENCES
The proposed change to cross-reference requirements, as described in the guidance on Page 12, section L, requiring Volume / CTD Module / Tab Identifier and Page Number, would result in system and process changes from the currently accepted electronic submission setup and requirements. Will alternatives to this process be explored, and (or) accepted?
3. COMMENTS ON CSR STRUCTURE
3.1 Tabs for appendices
Clarification on the FDA suggestion that “all appendices be separated by tabs, with the name of each on the tab”, is needed. Will providing CTD in electronic format be guided by the stated requirements, or will this section be in line with the spirit of the electronic submission guidelines, where table of contents and links can provide the necessary navigation properties.
Could “tab identifiers” be substituted by “cover pages” in certain circumstances (e.g. when providing literature references)?
3.2 Tabular listings for clinical studies
Are tabular listings (individual patient efficacy and safety listings, respectively) still required in a clinical study report (CSR), in addition to the sections 11 and 12 - US requirement?
Currently we do not submit patient listings (parts 3 and 4 of CSR) to European Authorities. How will CTD handle this global difference?
3.3 ISE and ISS
On Page 7, Section E.2., the draft guidance states: The submission of a separate ISE and/or ISS is not required when the information provided can be incorporated into the CTD summaries and overview. When the ISS or ISE is submitted, it should be included in Module 188.8.131.52, Meta-Analyses. Assuming that there would be cases in which we would still submit an ISS and/or ISE, would we include this (these) only in the Module 184.108.40.206., going to the FDA and remove it from the version of Module 220.127.116.11., going to the EU and Japan?