Drugs

Electronic Submissions Presentations

NOTE: On 4/24/2018 the FDA announced that it is extending the compliance date for submitting DMFs 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. 

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

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

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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