Drugs

Electronic Submissions Presentations

RAPS Regulatory Convergence
September 17-20, 2016, San Jose, CA

DIA Annual Meeting
June 26-30, 2016, Philadelphia, PA

DIA Regulatory Submissions, Information, and Document Management Forum
February 8-10, 2016, North Bethesda, MD

FDA/CDER Small Business and Industry Assistance (CDER SBIA) New Requirement for Electronic Submission of Drug Master Files (DMFs): What You Need to Know
February 4, 2016

GPhA Fall Technical Conference
November 4, 2015, North Bethesda, MD

DIA eRegulatory and Intelligence Annual Conference
May 11-13, 2015, Philadelphia, PA

FDA/CDER Small Business and Industry Assistance (CDER SBIA) GDUFA and You Conference 2014
March 27, 2014

EDM and ERS/eCTD: Impact of e-Initiatives on Content and Context: FDA Update/Progress Report
December 5, 2013
 (PDF)

  • eCTD Update, Mark Gray, Director, Division of Data Management Services & Solutions, Office of Business Informatics, CDER
  • Quality and Product Data Standards, Jared Lantzy, PMP, Division of Data Management Services & Solutions, Office of Business Informatics, CDER
  • Study Data Standards Update, Ron Fitzmartin, PhD, MBA, Office of Strategic Programs, CDER
  • Top Ten Issues with Data, Douglas Warfield, Ph.D., Division of Data Management Services & Solutions, Office of Business Informatics, CDER
     

2013 GPhA/FDA ANDA Labeling Workshop / USP Forum
September 11, 2013

 

Please contact esub@fda.hhs.gov, if you have any questions about the presentations included on this page.

 

Page Last Updated: 09/22/2016
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English