Drugs

CDER Small Business and Industry Assistance (CDER SBIA) Webinar - Electronic Submission Requirements for ANDAs: Are You Ready? - November 21, 2016

Image of SBIA Webinar 2016

 

The Food and Drug Administration, Center for Drug Evaluation and Research and Small Business and Industry Assistance (CDER SBIA), is pleased to announce the next webinar in our series.

The CDER SBIA webinars focus on a specific topic and provide an opportunity for small business and industry entities to learn more about the FDA and basic drug regulation. The webinars support CDER SBIA’s mission of promoting productive interaction with regulated industry by assisting small pharmaceutical business and industry with information relating to the development and regulation of human drug products.

On November 21, 2016, CDER SBIA hosted a LIVE webinar titled: Electronic Submission Requirements for ANDAs: Are You Ready?

This webinar was an opportunity to learn about the new electronic submission requirements and ask FDA questions.

During the webinar we provided information regarding the requirement that all ANDA Submissions be submitted in electronic Common Technical Document (eCTD) format starting May 5, 2017. The presentation addressed issues such as:

  • What are the eCTD specifications?
  • Where to find helpful how-to materials on eCTD submissions.
  • Common eCTD deficiencies
  • Changes in how OGD will handle eCTD deficiencies starting May 5, 2017.
  • A live Q&A session with FDA

The featured speakers were:

Jonathan Resnick
Project Management Officer
Division of Data Management Services and Solutions
Office of Business Informatics (OBI)
Office of Strategic Programs (OSP) | CDER

Julia Lee
Acting Deputy Director

Division of Filing Review

Office of Regulatory Operations (ORO)
Office of Generic Drugs (OGD) | CDER | FDA

Panelists (including above speakers)

Ginny Hussong
Director
Division of Data Management Services and Solutions
Office of Business Informatics (OBI)
Office of Strategic Programs (OSP) | CDER

This event has been pre-approved by RAPS as eligible for up to 1 credit towards a participant’s RAC recertification upon full completion.

For questions concerning the webinar, please contact CDER SBIA at:
(866)-405-5367 | (301)-796-6707

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Page Last Updated: 11/25/2016
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