Drugs

CDER Webinar - The Requirements to Provide Regulatory Submissions in Electronic Format – Standardized Study Data - February 9, 2015

On February 9,  2015, CDER hosted a webinar titled: "The Requirements to Provide Regulatory Submissions in Electronic Format – Standardized Study Data."  The featured speakers were Mary Ann Slack, Deputy Director  and Ron Fitzmartin, PhD, MBA. Senior Advisor, Office of Strategic Programs, Center for Drug Evaluation and Research (CDER). 

 
The webinar will provide an overview of the final guidances and related technical specifications that implements the electronic submission requirements of section 745A(a) of the FD&C Act for study data contained in new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologics license applications (BLAs), and investigational new drug applications (INDs).    
 
Guidances:
 
 
 
Technical Specifications Documents
 
 

 

View Presentation Here: https://collaboration.fda.gov/p1rgav4xlpz/

 

Download Presentation Slides: ESG Webinar (PDF – 1.4MB)


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