FDA Issues Draft Guidance on Electronic Submissions - - BioPharm International

ADVERTISEMENT

FDA Issues Draft Guidance on Electronic Submissions



FDA has issued a draft guidance relating to electronic submissions. Guidance for Industry: Providing Submissions in Electronic Format—Summary Level Clinical Site Data for CDER’s Inspection Planning is one in a series of guidance documents intended to assist sponsors and applicants making certain regulatory submissions to FDA in electronic format.

The draft guidance describes FDA’s recommendation that applicants submit summary-level clinical-site datasets in a standardized electronic format. This guidance generally applies to submissions of summary-level clinical-site datasets for new drug applications (NDAs), biologics licensing applications (BLAs), and NDA and BLA supplemental applications containing new clinical-study reports that are submitted to FDA’s Center for Drug Evaluation and Research (CDER). The purpose of the guidance is to assist applicants in the submission of a clinical dataset that describes and summarizes the characteristics and outcomes of clinical investigations at the level of the individual study site (summary-level clinical-site data). The summary-level clinical-site dataset is intended to facilitate the use of a risk-based approach for the timely identification of clinical investigator sites for on-site inspection by CDER during the review of marketing applications. The guidance refers to a number of technical specification documents and other resources. These technical specification documents and resources are available online to make them more accessible to applicants.

FDA also issued another draft guidance, Specifications for Preparing and Submitting Summary Level Clinical Site Data for CDER’s Inspection Planning, which provides current FDA specifications for preparing and submitting a summary-level clinical-site dataset in electronic form for NDAs, BLAs, and NDA or BLA supplemental applications submitted to FDA’s CDER.

blog comments powered by Disqus

ADVERTISEMENT

ADVERTISEMENT

Lilly to Acquire Novartis Animal Health
April 22, 2014
Novartis and GSK Trade Assets
April 22, 2014
Mallinckrodt to Acquire Questcor Pharmaceuticals
April 16, 2014
EMA Warns of Falsified Herceptin Vials
April 16, 2014
American CryoStem and Rutgers University File Joint Patent on Stem Cell Platform
April 11, 2014
Author Guidelines

Click here