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  1. Forms & Submission Requirements

Electronic Submissions Presentations

Electronic Submissions Presentations

NOTE: On 4/24/2018 the FDA announced that it is extending the compliance date for submitting Type III DMFs (packaging materials) in eCTD format to May 5, 2019. Presentations on submitting in eCTD format created prior to 4/7/2017 will have the incorrect compliance date for DMFs. Drug Master Files (DMFs) has more information on the extended eCTD compliance date. 

FDA/CDER Small Business and Industry Assistance (CDER SBIA) Generic Drug Forum (GDF) 2019
April 3-4, 2019, College Park, MD

PhUSE US Connect 2019
February 27, 2019, College Park, MD

DIA Regulatory Submissions, Information, and Document Management Forum
February 11-13, 2019, North Bethesda, MD

Association for Accessible Medicines
GRx + Biosims 2018
September 6, 2018, Baltimore, MD

DIA Global Boston 2018
June 24-28, 2018, Boston, MA

PhUSE US Connect
June 3-6, 2018, Raleigh, NC

FDA/CDER Small Business and Industry Assistance (CDER SBIA) Generic Drug Forum (GDF) 2018
April 12, 2018  

DIA Regulatory Submissions, Information, and Document Management Forum
February 5-7, 2018, North Bethesda, MD

  • Electronic Submissions Update, Ethan Chen, Acting Director, Division of Data Management Services and Solutions, Office of Business Informatics, CDER

AAM FallTech
November 6-8, 2017, North Bethesda, MD

DIA North Bethesda Feb 2017
February 6-8, 2017, North Bethesda, MD

General Updates, Jonathan Resnick, Division of Data Management Services & Solutions, Office of Business Informatics, CDER

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

  • 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.

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