fda立卷审查技术要求与案例.pdfVIP

Review of AN DA Filing Checklist and c ,oJmmon Re仙~se to Receive Issues Johnny Young, M.A.L.A. Overview of ANDAs 2 General Considerations 3 • ANDA Filing Checklist is Updated Quarterly (typically Mar-Jun-Sept- Dec) • Revisions are driven by updated recommendations/guidances pertaining to the technical reviews that are conducted by the different disciplines within OGD • Revisions may reflect future changes but are incorporated to provide applicants with ample notice • A copy of the most recent edition of the checklist may be found at: /downloads/ Drugs/ DevelopmentApprovalProcess/ HowDrugsareDe velopedandApproved/ApprovalApplications/Abbreviated NewDrugApplicationANDAGe nerics/ UCM151259.pdf • GDUFA payment and Type II API DMF Completeness Assessment confirmation 母 CTD ANDA Contents 5 Module 1 :Administrative - Form FDA 356h • Include 豆ll_facility information in Field 29 and use continuation pages as needed (do not use attachment sheets!) • Facility info should still be included in 3.2.S.2 and 3.2. P.3.1, respectively • Include all contact information and specific types of testing performed at the facility (e.g. “analytical testing of drug substance is not a sufficient description of the type of testing performed) 6 Module 1: Administrative (cont.) - Form FDA 356h (cont.) If the applicant is a foreign entity, fill out the U.S. agent information in Field