BPD Type 4 递交前会议(Presubmission Meeting),讨论一个完整的首次申请或补充申请的格式与内容。 申请人申请会议时需要根据具体情况通过各中心的文件室(纸质递交)或电子递交(Electronic Gateway)向FDA递交书面申请,并且书面申请需要满足所有适用的电子递交的要求。一般来说,申请人不需要按照顺序申请会议,比如,先申请BIA...
SUBMITTING CONFIDENTIAL INFORMATION IN AN OTC MONOGRAPH SUBMISSION 5 Contains Nonbinding Recommendations Draft — Not for Implementation 1 Providing Over-the-Counter Monograph 2 Submissions in Electronic Format 3 Guidance for Industry1 4 5 6 7 This draft guidance, when finalized, will represent the ...
Submission Guidance Medical Device Update: FDA Releases Final Pre-Submission GuidanceMedical Device Update: FDA Releases Final Pre-Submission GuidanceM. Elizabeth BiermanPhoebe Mounts, Ph.D
October 2015 1.0 Initial Version Updated/Clarified following sections: Section 2.3 (Transitioning to eCTD Format and Resubmission of Non- eCTD Documents), and subsections 2.3.1, 2.3.2, 2.3.3, 2.3.4 Section 2.4 (eCTD Leaf Titles) Section 2.6 (Presubmissions) Section 2.7 (Rolling Submission) Se...
Even though the FDA teams estimated that they devoted more than 25-fold the amount of interaction time for a typical presubmission, there was overall acceptance of the general principles and a belief that the program was worthwhile. For example, one FDA branch was particularly gratified by their...