Upcoming CDER Webinar on E-submissions – Monday, February 9th
On February 9, 2015 at 11 am (EST), CDER will host a webinar titled: "The Requirements to Provide Regulatory Submissions in Electronic Format – Standardized Study Data."
The featured speakers will be 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).
For more information: http://www.fda.gov/Drugs/
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