certification Debarment certification NDA and BLA Mapping Section CFR Citation/Source NUMBER 314.50(k) 601.2(a) 314.50(h) 314.53(e) 314.50(i) 314.52(e) 314.50(j) FDAAA 314.420(d) 314.50(g)(1) TITLE Financial certification and disclosure statement (Form FDA 3454 and Form FDA 3455) Patent ...
the applicant may file a paragraph IV certification with respect to the product patent or patent claim and a [section viii] statement that the product that is the subject of the application does not involve a patented method of use with respect to the method of use patent or patent claim....
(k) Statement 6 Truthful and Accuracy Statement 7 Financial Certification or Disclosure Statement FDA认证文件 8Executive Summary 9 Device Description 10 Substantial Equivalence Discussion 11 Proposed Labeling 12 Sterilization and Shelf Life FDA认证文件 13 ...
Debarment certification (FD&C Act 306 (k)(1)) 17. Field copy certification (21 CFR 314.50 (l)(3)) 18. User Fee Cover Sheet (PDUFA Form FDA 3397, GDUFA Form FDA 3794, BsUFA Form FDA 3792, or MDUFMA Form FDA 3601) 19. Financial Disclosure Information (21 CFR Part 54) 20. Other ...
1. FDA認證流程 FDA認證文件 1 Medical Device User Fee Cover Sheet (Form FDA 3601) 2 CDRH Premarket Review Submission Cover Sheet 3 510(k) Cover Letter 4 Indications for Use Statement 5 510(k) Summary or 510(k) Statement 6 Truthful and Accuracy Statement 7 Financial Certification or ...
Transfer of obligation 1.3.1.5 Change in ownership of an application or reissuance of license 1.3.2 Field copy certification 1.3.3 Debarment certification 1.3.4 Financial certification and disclosure 1.3.5 Patent and exclusivity 1.3.5.1 Patent information 1.3.5.2 Patent certification 1.3.5.3 Exclusivity...
As wereported last Thurdsay, Novartis’s Complaint alleges that FDA failed to require a split certification (Paragraph IV certification and “section viii” statement) with respect to U.S. Patent No. 5,246,937 (“the ‘937 patent”), one of five patents listed in the Orange Book for FAM...