FDA updates summary table forms for ANDA submissions containing clinical endpoint studies

The FDA has updated the summary table forms for abbreviated new drug application (ANDA) submissions containing clinical endpoint studies. The previous version has been updated, and in its place there are two separate documents: one for submissions containing comparative clinical endpoint bioequivalence studies, and another for submissions containing irritation/sensitization/adhesion (I/S/A) studies (specifically for transdermal and topical delivery systems [TDS]). Applicants are asked to refer to the Clinical Data Interchange Standards Consortium (CDISC) for submitting electronic datasets including Demographics, Medical History, Adverse Events, and other applicable data domains for ANDA submissions.

In addition, the summary table forms for aqueous nasal spray products have been updated. The new version includes updated summary tables for six in vitro studies and batch information based on the revised Nasal Product Specific Guidances, as well as updated summary tables for pre-study method validation and formulation tables.

The Study Data Standards Resources available on FDA.gov include:

• FDA’s December 2014 final guidance on study data standards, Providing Regulatory Submissions in Electronic Format - Standardized Study Data
• Relevant technical specifications such as: 
• FDA Data Standards Catalog
• The Study Data Technical Conformance Guide

• “Electronic Submission Requirements for ANDAs: Are You Ready?” Webinar

Under section 745A(a) of the Food, Drug & Cosmetic Act, separate Agency-wide guidances specify the electronic formats, subject matter, and scope of applicability for certain submissions, including submissions to ANDAs. As these are finalized guidances and subject to described timetables for implementation, these guidances are binding and the electronic format(s) specified in that guidance must be used for submissions to ANDAs.

Questions and general information regarding the preparation of submissions in electronic format may be directed to the FDA Center for Drug Evaluation and Research (CDER) at esub@fda.hhs.gov or the FDA Center for Biologics Evaluation and Research (CBER) at esubprep@cber.fda.gov. Questions regarding submission of datasets to CDER may be sent to edata@fda.hhs.gov