FDA于2012年12月28日发布了更新版ANDA FILING CHECKLIST (CTD or eCTD FORMAT) FOR COMPLETENESS AND ACCEPTABILITY of an APPLICATION。
与三个月前发布的上一版相比，内容更新如下：
1. 第2页，增加了第5个勾选项：5. GDUFA Obligations Met □ Yes
2. 第6页，MODULE 2.7: Clinical Summary，生物等效性实验结果表3、表10、表16有更新：
Table 3. Statistical Summary of the Comparative BA Data
Table 10. Study Information
Table 16. Composition of Meal Used in Fed Bioequivalence Study
3. 第7页，MODULE 3: 3.2.S DRUG SUBSTANCE中3.2.S.4.4 Batch Analysis
第2条，由"Applicant certificate of analysis"更新为"Drug Product manufacturer's Certificate of analysis"
4. 第9页，MODULE 3: 3.2.P DRUG PRODUCT (Continued)中3.2.P.8.3 Stability Data
第1条，Accelerated stability data增加了c. for liquid products, inverted or horizontal storage orientation
并增加了第3、第4条：
3. Date accelerated stability samples placed in stability chamber
4. Date accelerated stability sample removed from stability chamber for each testing
time point
