How can I limit my submission to 15 pages including attachments as required by the regulation, and still provide all the information FDA needs to make its decision?14 IV. CONCLUSION 15 APPENDIX: RFD SCREENING CHECKLIST16 iv Guidance for Industry How to Write a Request for Designation (RFD) ...
•Submission Sub-Type(e.g. Application , Amendment, Resubmission) Valid Submission typeswill be based on the Application Type, e.g., an efficacy supplement can be associated with an NDA or BLA but not an IND. The FDA provided a figure to illustrate how the approach works in comparison wi...
FDA对乙酰氨基酚注射液临床研究资料