Biologics Consulting Group - Comment

1.11 Information amendment: Information not covered under modules 2 to 5 Not all 1.11 subheadings correspond clearly with the eCTD modules. "1.11.1 Quality information amendment" maps to Module 3. We suggest changing "1.11.2 Safety information amendment" to "1.11.2 Nonclinical information amendment" to correspond with Module 4. We also suggest changing "1.11.3 Efficacy information amendment" to "1.11.3 Clinical information amendment" to correspond with Module 5. 1.12 Other correspondence We suggest adding a "1.12.x Response to FDA request for information" heading. The 1.11.x headings can be used for responses but the new heading would cover situations where a response would not be considered an amendment. If additional specifity is desired, a new 1.x heading could be created with subheadings for type of content. 1.12.17 Orphan drug designation We suggest that this be added as a new 1.x section rather than under 1.12. The new section would be: 1.21 Orphan Drug 1.21.1 Designation Request 1.21.2 Correspondence 1.21.3 Annual Reports