Agency Presentations

Any organization filing regulatory submissions on a consistent basis must stay informed of the latest Agency guidance and GlobalSubmit engages in a routine dialogue with regional authorities, and is pleased to give you access to the latest webinars and presentations.

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

Electronic Submissions Update, Ginny Hussong, Director (Acting), Division of Data Management Services & Solutions, Office of Business Informatics, CDER

FDA Update: Submission of Promotional Materials, CDR Roberta Szydlo, RPh, MBA, RAC, Senior Regulatory Review Officer, Office of Prescription Drug Promotion, CDER

FDA's Module 1 Update, Jared Lantzy, PMP, Division of Data Management Services & Solutions, Office of Business Informatics, CDER

eCTD IV Update, Mark Gray, Senior Project Manager, CBER

Current CDER Initiatives, April 20, 2015

Douglas C. Throckmorton, M.D., Deputy Director for Regulatory Programs, Center for Drug Evaluation and Research (CDER), FDA

Creating The Path to Success with GDUFDA, February 10, 2015

Kathleen Uhl, MD, Director, Office of Generic Drugs, FDA OGD Keynote Address

GDUFA Regulatory Science Update, February 10, 2015

Robert Lionberger, Ph.D., Director, Office of Research and Standards, OGD, CDER, FDA

Electronic Submissions - The Requirement for Standardized Study Data, February 9, 2015

Mary Ann Slack, Deputy Director, Office of Strategic Programs; Ron Fitzmartin, PhD, MBA, Sr. Advisor, Office of Strategic Programs

CDER New Drug Review: 2014 Update, December 11 2014

John K. Jenkins, M.D., Director Office New Drugs, Center for Drug Evaluation

Global Drug Development and its Impact on CDER's Drug Review Process Symposium, June 24, 2014

Robert Isner, Associate Director for Policy Development, Office of Pharmaceutical Quality

Draft Guidance for Industry ANDA, June 12, 2014

Content and Format of Abbreviated New Drug Applications, Elizabeth, JD, Office and Generic Drugs

Optimizing your eCTD ANDA, March 27, 2014

GDUFA and You 2014, Jared Lantzy, PMP, Data Management Solutions Team, CDER Office of Business Informatics

Update on GDUFA and FDA's Office of Generic Drugs, February 20, 2014

GPhA Annual Meeting, Uhl, MD, Acting Director, Office of Generic Drugs CDER/FDA

Approved Drugs 2013: Report Issued January 2014

Novel New Drugs 2013 Summary, US FDA Center for Drug Evaluation and Research

CDER New Drug Review: 2013 Update, December 11, 2013

FDA/CMS Summit, John K. Jenkins, M.D., Director, Office of New Drugs Center for Drug Evaluation and Research

EDM and ERS/eCTD: Impact of e-Initiatives on Content and Context, December 5, 2013

DIA EDM Webinar eCTD Update, Mark Gray, Director, Division of Data Management Services & Solutions

CDER Small Business Webinar on Guidance for Industry, November 18, 2013

ANDA Submissions – Refuse-to-Receive Standards, Johnny Young, Office of Generic Drugs (OGD)/CDER/FDA

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

Submitting High Quality eCTD Submissions to FDA/OGD, Constance Robinson, Regulatory Information Specialist, Division of Data Management Service and Solutions CDER

DIA 2012 Annual Meeting, Philadelphia, PA June 27, 2012

The State of Electronic Submissions at CDER, Virginia Hussong, Office of Business Informatics, OPI, CDER

eCTD Module 1 Update Part 1, Constance Robinson, Regulatory Information Specialist, eSubmission Support, Office of Business Informatics, OPI, CDER

eCTD Module 1 Update Part II, Mark Gray, Director, Division of Regulatory Review Support, Office of Business Informatics, CDER

Draft Module 1 Update 1, 1.15 Promotional Materials, Marci Kiester, Pharm D, Associate Director of Operations, OPDP, CDER

DIA Module 1 Townhall, February 9, 2012

eCTD M1 Update: General Overview of the Comments, Constance Robinson, Regulatory Information Specialist, eSubmission Support, Office of Business Process Support, CDER

Draft Module 1 Update (1.15 Promotional Materials), Marci Kiester, Pharm D, Associate Director of Operations, OPDP (formerly DDMAC), CDER

Key Modifications to Module 1, Jared Lantzy, Regulatory Information Specialist, Electronic Submission Support Team, Office of Business Informatics